Overview:
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the understanding the fundamentals of a HIPAA compliance program.
If your healthcare practice, business, or organization needs to understand the requirements of HIPAA compliance or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive course.
Why should you Attend:
With HIPAA data breaches occurring at an alarming rate and with an increase in enforcement, fines and penalties, organizations need to fully understand the requirements of a compliance program. This webinar will break down the complexities of HIPAA compliance requirements in an easy to understand format. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to taken to mitigate risk.
After completing this course, a Covered Entity or Business Associate will know how to assess their current compliance program and determine if their organization is meeting all of the HIPAA requirements.
Areas Covered in the Session:
Why was HIPAA created?
Who Must Comply with HIPAA Requirements?
What are the HIPAA Security and Privacy Rules?
What is a HIPAA Compliance Program?
What is a HIPAA Risk Management Plan?
What is meant by "Required" and "Addressable" Implementation Specifications?
What are Administrative, Technical, and Physical Safeguards Requirements?
What is a HIPAA Risk Assessment?
What are HIPAA training requirements?
What is a HIPAA data breach and what happens if it occurs?
What are the penalties and fines for non-compliance and how to avoid them?
Creating a Culture of Compliance
Questions
Who Will Benefit:
Compliance Officer
HIPAA Privacy Officer
HIPAA Security Officer
Medical/Dental Office Managers
Practice Managers
Information Systems Manager
Chief Information Officer
General Counsel/lawyer
Practice Management Consultants
Any Business Associates that accesses protected health information
IT Companies that support Medical/Dental practices or other healthcare organizations
Speaker Profile:
Jay Hodes president of Colington Security Consulting, LLC, which provides HIPAA consulting services for healthcare providers and business associates. Mr. Hodes has over 30 years of combined experience in risk assessments, site security evaluation, regulatory compliance, policy and procedures assessments, and federal law enforcement management. He is the former Assistant Inspector General for Investigations at the U.S. Department of Health and Human Services.
Mr. Hodes has been the keynote speaker and provided presentations regarding HIPAA compliance to a number of professional healthcare organizations. He has published over 30 educational articles regarding HIPAA compliance, been featured in Part B news articles and provided a guest post for the Electronic Health Reporter.
Price : $139.00
Contact Info:
MentorHealth
Phone No: 1-800-385-1607
FaX: 302-288-6884
support@mentorhealth.com
Event Link: http://www.mentorhealth.com/control/w_product/~product_id=800898LIVE?channel=mailer&camp=Webinar&AdGroup=worldconferencecalendar_Jan_2017_SEO
http://www.mentorhealth.com/
LinkedIn Follow us https://www.linkedin.com/company/mentorhealth
Twitter Follow us https://twitter.com/MentorHealth1
Facebook Like us https://www.facebook.com/MentorHealth1
HIPAA Compliance What You Need to Know 2017
↧
↧
2nd Pharma Digital & Multichannel Marketing Boot Camp
The 2nd Pharma Digital & Multichannel Marketing Boot Camp uses a combination of lectures, class discussions and hands-on exercises with people who want to understand how to create effective and sophisticated digital and multichannel marketing (MCM) strategies. This intensive two-day program not only teaches you strategic processes, but also gives you the tools and skills you need to gather insights and develop your own digital and multichannel programs.
Time: 8:00 am - 3:00 pm
Price:
Early Bird Pricing (before February 5, 2016): USD 1995
Standard Pricing (after February 5, 2016): USD 2095
Onsite Pricing: USD 2195
Speakers: Scott Friedberg, Dartview Associates
↧
FMEA Risk Assessment for Healthcare Decision Making
Description
Failure Modes & Effects Analysis (FMEA) is a valuable risk assessment process that should be used more often in healthcare problem solving and decision making. This webinar's instructor has worked with FMEA in healthcare settings for the past 12 years. She provides a quick lesson in how to use FMEA, and shares varied examples of benefits for you and your organization.
Objectives of the Presentation
FMEA assists in more robust decision making: grounded in analysis vs. opinion
Developing a problem solving culture leads to more proactive thinking vs. 'firefighting' reactions
Learn how to use FMEA and when to use this important risk assessment
Understand the relevance of the FMEA process to healthcare business processes, clinical operational work flows, facility changes and new space planning, etc.
Why Should you Attend
Failure Modes and Effects Analysis (FMEA) was developed outside of health care and is now being used in health care to assess risk of failure and harm in processes and to identify the most important areas for process improvements. FMEA has been used by hundreds of hospitals in a variety of Institute for Healthcare Improvement programs. Attend this webinar to learn how to use FMEA Risk Assessment as a tool in Healthcare Decision Making.
Who will Benefit
Healthcare Industry
Healthcare VP/Director/Manager
Director/Manager of Healthcare Quality
Director/Manager of Healthcare Process Improvement
VP of Healthcare Operations /Chief Operating Officer
Healthcare Risk Manager/Safety Officer.
For Registration
http://onlinecompliancepanel.com/webinar/FMEA-RISK-ASSESSMENT-501873/NOVEMBER-2016-ES-WORLDCONCAL
Note: Use Promo code HYULK and get 10% off on registration (Valid till November 30th 2016)
↧
Validation of GC/ GC-MS methodologies - By Compliance Global Inc
Overview :
Instrumental gas chromatography, either as GC or GC-MS, are common techniques in laboratories that do regulatory-compliance work.
Why Should You Attend :
In order to meet US EPA or FDA requirements, a method must meet many stringent requirements.
Areas Covered in this Webinar :
The more important of these for specific analytical methods are method validation and instrument validation. To not do so is a non-compliance in which any data is not usable or reportable.
Learning Objectives :
Instrument Validation
o The gas system
o The injector
o The column
o The detection system
o The data system
Method Validation
o Accuracy
o Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
o Limits of detection and quantitation, linearity
o Selectivity, interferences, and specificity
o Sensitivity
o Solution stability
Who Will Benefit :
Lab Chemists
Lab Managers
Lab Technicians
Lab Analysts
Industries into Compliance Methodology (Biotech, Pharma) Companies into Environmental Compliance or EPA
Chemists and Laboratory Assistants who perform HPLC or UPLC analyses under GLP or ISO 17025
For more information, please visit : https://www.complianceglobal.us/product/700570/JohnCFetzer/validation-of-gc-gc-ms-methodologies%20/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile :
John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers onl iquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
↧
Tips for Surviving an OSHA Audit Inspection - By Compliance Global Inc
Overview :
The Occupational Safety and Health Administration (OSHA) is increasing its enforcement activities in many industries. Learn what you can do to be prepared for surviving an OSHA audit at your facility.
The Occupational Safety and Health Administrations (OSHA) mission is to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. As a part of working towards this mission, OSHA conducts workplace inspections across the country.
Why Should You Attend :
OSHA has been increasing its inspection intensity in recent years. In fiscal year 2015, OSHA conducted over 35,000 inspections, the majority of which were unannounced. OSHA has also recently made significant increases to its penalty amounts for citations. The agencys current philosophy is that major citations should be publicized to deter other companies from slipping out of compliance.
Better understanding the OSHA compliance inspection process and what you can do to be ready for an inspection can help you avoid being the subject of the next OSHA press release highlighting company citations. How you handle the inspection itself can also play an important role in the outcome. Finally, it is important to understand your options after the inspection is complete.
Join this webinar to learn best practices for what you should do before, during and after an OSHA inspection.
Areas Covered in this Webinar :
Recent OSHA inspection trends
Most frequently issued OSHA citations
Recent changes to the OSHA penalty structure
Recent changes to how OSHA weights different types of inspections
Tips for OSHA audit
OSHA inspection process
Dos and Donts During an OSHA inspection
What to expect after an OSHA inspection?
Considerations for contesting citations
Learning Objectives :
How to prepare for an OSHA inspection
Best practices during an OSHA inspection
What to do after an OSHA inspection
Who Will Benefit :
Employers subject to OSHA Regulations,
Facility Managers
Environmental Safety and Health Professionals,
Compliance Officers,
Safety Managers/ Trainers,
Operations Managers,
Engineers
For more information, please visit : https://www.complianceglobal.us/product/700620/LowellRandel/tips-for-surviving-an-osha-audit-inspection/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile :
Lowell Randel currently serves as Vice President, Government and Legal Affairs for the Global Cold Chain Alliance (GCCA). He is responsible for advancing the industrys interests with the U.S. Congress and Administration and helps association members deal with regulatory compliance, with an emphasis on EPA, OSHA, and DHS. Lowell has over 20 years of experience working in Washington, DC ranging from private sector representation to government service.
Prior to joining GCCA, Lowell served as the Deputy Assistant Secretary for Congressional Relations at the United States Department of Agriculture (USDA). While in this role, Lowell worked closely with the Secretary of Agriculture and across all USDA agencies to coordinate legislative policy and functioned as a primary contact between the Department and Congress.
Lowell holds a Bachelors degree in agricultural economics and Masters degree in agricultural development, both from Texas A&M University. He also holds a Juris Doctorate from George Mason University School of Law.
↧
↧
A New Civil Rights Law for Health Providers, Employees of Health Programs, and Health Insurance ...
Overview :
Healthcare providers such as hospitals, clinics, physicians, community health centers, nursing homes, home care agencies, health insurance companies (including those found in the Health Insurance Marketplaces), and any other covered entities which operate a health program or activity have a new civil rights law to incorporate into their operations. The Department of Health and Human Services (HHS) recently issued its final rule to drive health equity and diminish healthcare disparities.
Section 1557 is the first federal civil rights law to specifically forbid discrimination of patients, sex discrimination in both healthcare and healthcare coverage plans by any provider or insurance company that receives federal funding such as Medicare and Medicaid, and so much more.
Sex discrimination also includes discriminatory treatment on the basis of pregnancy, false pregnancy, termination of pregnancy, recovering from pregnancy, childbirth and related medical conditions, sex stereotyping, and gender identity.
It is not only sex discrimination that the ACA prohibitsdiscrimination based on race, color, national origin, age, disability are also protected classes from discrimination. Covered Entities are instructed to provide language assistance for individuals with limited English skills with new rules about who can provide that assistance, and in what format, such as translation of documents and websites and taglines. Individuals with disabilities are likewise protected including a requirement to make websites and other electronic information accessible to those with disabilities.
Why Should You Attend :
The U. S. Department of Health and Human Services, Office for Civil Rights issued the new regulations for Section 1557 of the Affordable Care Act. This act deals with nondiscrimination in healthcare and provides important new protections for patients including broad rules dealing with sex discrimination. Ensuring the new law is implemented will decrease the risk of liability, ensure quality and equitable care and insurance coverage of all patients thereby enhancing quality care of patients.
Areas Covered in this Webinar :
Sample taglines in variety of languages (website) as required by ACA
Sample notice to be posted as required by ACA
Sample grievance procedure as required by ACA
Internet links to resources
Discussion regarding healthcare disparities with LGBT patients,
Discussion of the first ACA lawsuit dealing with abuse of a transgender patient and its implications for all hospitals
Discussion regarding new requirements for auxiliary aids and services for disabled patients
Discussion regarding new requirements for auxiliary aids and services for those who speak English as a second language
Learning Objectives :
To review the 4 civil rights laws incorporated into Section 1557
To discuss ACAs new requirements to prevent sex discrimination
To review the mandates for aids for the disabled and those with English as a second language
To explore ACAs new requirements for health insurance companies
To identify how HHS Office for Civil Rights (OCR) defines covered entities
To list the wide variety of federal funding that applies to the ACA
To analyze Association Discrimination related to association with members of a protected class
To examine covered entities required administrative steps
To discuss OCRs role in enforcing Section 1557
To provide resources for implementing Section 1557
Who Will Benefit :
Physicians,
Hospitals,
Clinics,
Pharmacies,
Home/Public Health Agencies,
Health Insurance Companies,
Dentists/Therapists,
Nurse Practitioners,
Medical Technicians/Assistants,
Administrative Assistants,
Compliance Managers,
All Management including Team Leaders, Supervisors, Middle Managers, Directors, and Senior Leaders, Administrators, Human Resources Professionals including Generalists and HR Managers, Risk Managers and Attorneys
For more information, please visit : https://www.complianceglobal.us/product/700621/DrSusanStrauss/Section-1557-of-the-Affordable-Care-Act/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile :
Dr. Susan Strauss RN Ed.D., has worked as a registered nurse (RN) in a variety of nursing specialties. She has also been the director of healthcare quality improvement, director of education and development, and held other healthcare leadership roles.
One of Dr. Strausss areas of expertise is with bullying and harassment in healthcare- working as an expert witness for lawsuits, training, and conducting investigations. She researched physician abuse to RNs in the OR to determine if the abuse varied based on the gender of the nurse.
Dr. Strauss has authored over 30 books, book chapters, and articles, and has been featured on local, national and international media. Susan has conducted seminars and consulted with organizations, including healthcare, globally.
In addition to her RN, Susan has amasters degree in community health science, and holds a doctorate in organizational leadership.
↧
WELCOME TO SINGAPORE AND ASVAC 2017 The 6th Asian Vaccine Conference
The 6th Asian Vaccine Conference (ASVAC 2017), to take place in Singapore on 27-29 April 2017, is the regional platform where all stakeholders and advocates for wider immunization coverage gather to find comprehensive solutions for the introduction of new vaccines and programmes to eradicate illness, including:
Public and Private Donors and Health Organisations
Vaccine Manufacturers, National Immunization Programme Managers and Government Policymakers
Senior-Level Pediatricians, Infectious Disease and Tropical Medicine Specialists
Together, we will work with Immunization Partners of Asia Pacific (IPAP) to realise the conference theme of #YOLO: Let #VaccinesProtect You, sharing our knowledge, experience and strategies for the cost-effective introduction of new vaccines.
High on the agenda for new vaccine introduction at the conference will be such crucial topics as:
Justification, goals and objectives, and anticipated impact on the immunization programme and health system
Specific target populations, phased vs. nationwide introduction, and delivery strategies
Coordination mechanisms and key partnerships
Opportunities, key issues and weaknesses to be addressed
Major activities expanding health worker capacity, reaching the hard-to-reach, improving cold chain and logistics systems
Our shared belief that a healthy life is a basic human right drew hundreds of the best and brightest to previous conferences, and we expect the turnout at ASVAC 2017 to be even more impressive in terms of numbers and results.
Price:
please refer to website: USD 0
Time: 9:00 am - 5:00 pm
↧
Cardiometabolic Health Congress-Regional-Chicago, IL
This meeting will provide updates on current, new, and emerging therapies, treatment guidelines, and practical strategies to personalize care and empower patients to reduce global cardiometabolic risk and improve patient outcomes. The integrated curriculum will address such clinically relevant topics in cardiometabolic health as CVD prevention, diabetes, hypertension and heart failure, and nutrition.
The CMHC has over a decade of history bringing together experts across the spectrum of diabetes, obesity, and cardiovascular disease to share ideas and foster collaborations. The program is at the cutting edge of science, translating the latest research to practical approaches for the entire multidisciplinary health care team. CMHC offers live conferences and online educational programs.
The target audience for this conference is an interdisciplinary mix of mid to advanced level health care professionals, including primary care clinicians, internists, cardiologists, endocrinologists, obesity specialists, lipidologists, nurse practitioners, physician assistants, pharmacists and Certified Diabetes Educators.
For exhibitor/sponsorship opportunities, please contact Kathleen Powell at 561-997-0112 x7507 or kathleen@cardiometabolichealth.org.
Time: 7:15 am to 5:30 pm
URL:
Booking: https://go.evvnt.com/73992-1
Price: USD 79
↧
MACRA Final Rule: Master the necessary Requirements to Avoid Medicare Payment Cuts before ...
Description
On October 14th, 2016, CMS released the final rule outlining how MACRA will replace the current Medicare payment system with the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). The webinar will provide hospitals and healthcare organizations with strategies to analyze their current infrastructure, evaluate their readiness for the MACRA regulation, identify key areas of improvement and estimate their financial impact under the regulation. In coming years, your income could either rise or fall depending on how well you navigate this value-based care landscape. Are you prepared?
Objectives of the Presentation
Defines what is MACRA?
Who is eligible in 2017
Outlines each track of MACRA
Merit-based Incentive Program (MIPS)
Advanced Alternative Payment Method (APMs)
Review the payment cycle
Review the deadlines for performance data submission
How a clinician will be scored under new rules
Why Should you Attend
Based on MACRA, your Medicare reimbursement will be increased or decreased depending on how well you perform on a revised set of quality and cost metrics. And to make it worse, you have just a few weeks to begin complying with these new requirements. It's important to receive the training because Medicare is changing the way they reimburse physicians, physician assistant and nurse practitioners. If they do not understand the new rules, they will receive penalties to their reimbursement in 2019. The webinar will provide an overview of the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Model (APM) incentive payment provisions under MACRA, collectively referred to as the Quality Payment Program.
How you report your 2017 MACRA metrics will make a significant difference in your future Medicare reimbursement. It's vitally important that you figure this out now. During your first year of reporting your quality and cost MACRA data, you have the opportunity to mitigate your risk of future Medicare reimbursement cuts, but you have to know how.
Areas Covered
Areas that will be covered are listed below.
Explains the background of MACRA
Eligibility - Who is included in the Quality Payment Program?
Explains the tracks to choose from
Advanced Alternate Payment programs (APM'S)
What is an Advanced APM?
Who qualifies to be and Advanced APM?
Merit Based Incentive Payment Systems (MIPS)
What is MIPS?
Who qualifies for MIPS?
Reporting methodologies
How clinicians will be scored
Deadlines
When does the Quality Payment Program start?
When is the Submission Deadline?
Payment cycle
How to get bonus points
How to set up for start of 2017
How will the Quality Payment Program in 2017 change my Medicare payments in 2019?
Who will Benefit
Physician assistant
Nurses
Office managers
C-suite of hospitals and health plans
Senior level administrators
Directors
Specialist
Clinical management and practice administrators
Topic Background
In April, the Centers for Medicare & Medicaid services published a proposed rule in implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). CMS received numerous comments from small and rural providers expressing concerns over reporting requirements and their ability to meet the proposed guidelines. Those concerns were taken into consideration and the Final Rule was released Oct. 14.
For Registration
http://onlinecompliancepanel.com/webinar/MACRA-FINAL-RULE-501899/DECEMBER-2016-ES-WORLDCONCAL
Note: Use Promo code AAGHU and get 10% off on registration (Valid till December 31st 2016)
↧
↧
Cardiometabolic Health Congress-Regional-Atlanta, GA
This meeting will provide updates on current, new, and emerging therapies, treatment guidelines, and practical strategies to personalize care and empower patients to reduce global cardiometabolic risk and improve patient outcomes. The integrated curriculum will address such clinically relevant topics in cardiometabolic health as CVD prevention, diabetes, hypertension and heart failure, and nutrition.
The CMHC has over a decade of history bringing together experts across the spectrum of diabetes, obesity, and cardiovascular disease to share ideas and foster collaborations. The program is at the cutting edge of science, translating the latest research to practical approaches for the entire multidisciplinary health care team. CMHC offers live conferences and online educational programs.
The target audience for this conference is an interdisciplinary mix of mid to advanced level health care professionals, including primary care clinicians, internists, cardiologists, endocrinologists, obesity specialists, lipidologists, nurse practitioners, physician assistants, pharmacists and Certified Diabetes Educators.
For exhibitor/sponsorship opportunities, please contact Kathleen Powell at 561-997-0112 x7507 or kathleen@cardiometabolichealth.org.
Time: 7:15 am - 5:30 pm
Price: USD 79
↧
eyeforpharma Philadelphia 2017
Its eyeforpharma Philadelphias 15th year; already the largest, most senior and most influential forum for commercial pharma executives, but now in line for a reboot as we aim to position our industry ahead of the curve. Victory requires far more than just SFE, MCM and KAM it means becoming the health partner of choice. We, as patients, are becoming consumers. Were looking for value. We expect quality and real-time delivery. We are more than just empowered were in charge.
This is your opportunity to join the discussion with 2 days of expert presentation, interactive panels, keynote presentations and exclusive networking. Join the most forward thinking speaker from across North America including C-level, VPs and industry leaders from Shire, Otsuka, GSK, Novartis, Pfizer, Google, Sanofi, Takeda and many more. This is the ideal place to ensure your commercial strategy is prepared for 2017 and beyond. Full meeting details here https://goo.gl/HAFSus
URL:
Booking: https://go.evvnt.com/74173-1
Price:
Pharma Pass: USD 1699
Time: 9:00 am - 3:00 pm
↧
12th Annual Cardiometabolic Health Congress
The CMHC has over a decade of history bringing together experts across the spectrum of diabetes, obesity, and cardiovascular disease to share ideas and foster collaborations. The program is at the cutting edge of science, translating the latest research to practical approaches for the entire multidisciplinary health care team. CMHC offers live conferences and online educational programs.
The target audience for this conference is an interdisciplinary mix of mid to advanced level health care professionals, including primary care clinicians, internists, cardiologists, endocrinologists, obesity specialists, lipidologists, nurse practitioners, physician assistants, pharmacists and Certified Diabetes Educators.
For exhibitor/sponsorship opportunities, please contact Kathleen Powell at 561-997-0112 x7507 or kathleen@cardiometabolichealth.org.
Time: 12:00 pm to 12:00 pm
Price:
Allied Health registrations start from: USD 395
Pysician registrations start from: USD 395
Fellows/Residents/Students registrations start from: USD 0
Industry registrations start from: USD 695
Speakers: Steven E. Nissen, MD, MACC, Peter Libby, MD, Suzanne Oparil, MD, Ronald C. Kahn, MD, Subodh Verma, MD, PhD, FRCSC
↧
Conference on HIPAA Security & Privacy Official - Roles and Responsibilities 2017
Overview:
Being the HIPAA Security and Privacy Official involves not only ensuring you know the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program.
If your HIPAA Security and Privacy Official needs to understand what all the HIPAA requirements are or make sure the current program are adequate and can withstand government scrutiny, please join us for this informative and interactive seminar.
Why should you attend:
The HIPAA Security and Privacy Official is the backbone of any organization's compliance program. Often times this role is assigned as collateral duty in smaller organizations. Regardless the size of an organization, the HIPAA Security and Privacy Official must know all the requirements for compliance. This is a critical element of the position.
Attendees will leave the course clearly understanding the role and all the requirements as the designated as a HIPAA Security and Privacy Official. This seminar will cover reviews, creation, and amending policy and procedure. After completing this course, a HIPAA Security and Privacy Official will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations.
Areas Covered in the Session:
Why was HIPAA created?
The Role and Responsibilities of the HIPAA Security and Privacy Official
Complying with HIPAA Requirements?
What are the HIPAA Security and Privacy Rules?
What is a HIPAA Compliance Program?
What is a HIPAA Risk Management Plan?
What is meant by "Required" and "Addressable" Implementation Specifications?
What are Administrative, Technical, and Physical Safeguards Requirements?
Developing Policies and Procedures - Practical Exercise
What is a HIPAA Risk Assessment?
Risk Assessment - Practical Exercise
What are HIPAA training requirements?
What is a HIPAA data breach and what happens if it occurs?
What are the penalties and fines for non-compliance and how to avoid them?
Helping a HIPAA Security and Privacy Official create a culture of compliance
Q&A
Who will benefit:
Compliance Officer
HIPAA Privacy Officer
HIPAA Security Officer
Medical/Dental Office Managers
Practice Managers
Practice Owners
Information Systems Manager
Chief Information Officer
General Counsel/lawyer
Practice Management Consultants
Agenda:
Day 1 Schedule
Lecture 1:
What is HIPAA, HITECH & the Omnibus Rule
The Role and Responsibilities of the HIPAA Security & Privacy Official Job Descriptions
Lecture 2:
Privacy Rule Requirements
Reviewing Notice of Privacy Practices (NPP)
Authorized and Permitted Disclosures
Marketing in a HIPAA compliant world
Lecture 3:
Security Rule Requirements
Administrative, Technical, and Physical Safeguards
How to Perform HIPAA Risk Assessments
Lecture 4:
Risk Assessment - Practical Exercise
Day 2 Schedule
Lecture 1:
Review of Risk Assessment Practical Exercise
Remediation and Required Follow Up
Lecture 2:
What is a HIPAA Risk Management Plan
Developing Policy and Procedure
Reviewing Policy and Procedure
Lecture 3:
Policy and Procedure - Practical Exercise
Lecture 4:
Review Policy and Procedure Practical Exercise
Summary & Closing Remarks
Q&A
Speaker:
Jay Hodes
President and Founder, Colington Security Consulting, LLC
Jay Hodes is a leading expert in HIPAA compliance and President of Colington Consulting. His company provides HIPAA consulting services for healthcare providers and business associates. Mr. Hodes has over 30 years of combined experience in risk assessments, site security evaluation, regulatory compliance, policy and procedures assessments, and Federal law enforcement management. He is the former Assistant Inspector General for Investigations at the U.S. Department of Health and Human Services.
Mr. Hodes has been the keynote speaker and provided presentations regarding HIPAA compliance to many professional healthcare organizations. He has published over 35 educational articles regarding HIPAA compliance, been featured in Part B News articles, the Report on Patient Privacy, provided a guest post in the Electronic Health Reporter, and provided advice on HIPAA compliance to Renal & Urology News and the Virtru.com blog.
Mr. Hodes is a member of member of the American Institute of Healthcare Compliance, Healthcare Information and Management Systems Society, American Society for Industrial Security, Metro Collaborative, the Practice Management Association of Northern Virginia, the Health Technology Forum: DC, Association of Elderservice Professionals (VA) and the Loudoun Seniors Interest Network.
Mr. Hodes is certified by the New Jersey Board of Dentistry and the Maryland State Board of Dental Examiners to provide continuing education classes in HIPAA compliance. In his free time, Mr. Hodes is a volunteer for Lab Rescue of the Labrador Retriever Club of the Potomac and the non-profit organization, Outer Banks Sporting Events.
Location: Philadelphia, PA Date: January 5th & 6th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Garden Inn Philadelphia Center City
1100 Arch Street, Philadelphia, Pennsylvania, 19107, USA
Price:
Price: $1,295.00 (Seminar Fee for One Delegate Without Stay)
Until December 15, Early Bird Price: $1,295.00 from December 16 to January 3, Regular Price: $1,495.00
Price: $1,695.00 (Seminar Fee for One Delegate With Stay)
Until December 15, Early Bird Price: $1,695.00 from December 16 to January 3, Regular Price: $1,895.00
Register for 5 attendees (With stay) Includes Price: $4,323.00 $8,475.00 You Save: $4,152.00 (49%)*
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/2eMW0Cs-HIPAA-Security-Privacy
Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
↧
↧
Seminar on Applied Statistics for Scientists and Engineers 2017
Course "Applied Statistics for Scientists and Engineers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices.
Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices.
This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, industry-specific applications are presented for the participants.
Why should you attend:
21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods across the product quality lifecycle.
According to the Quality System Regulation (QSR) for medical devices, "Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, verifying the acceptability of process capability and product characteristics." Although there are many statistical method that may be applied to satisfy this portion of the QSR, there are some commonly accepted methods that all companies can and should be using to develop acceptance criteria, to ensure accurate and precise measurement systems, to fully characterize manufacturing processes, to monitor and control process results and to select an appropriate number of samples.
According to both 21 CFR and guidance documents, the need for statistical methods is well established from discovery through product discontinuation. 21 CFR specifies the "the application of suitable statistical procedures" to establish both in-process and final specifications. The guidance documents necessitate the application of statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring the manufacturing process is in control and is capable.
This course provides instruction statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.
Areas Covered in the Session:
Objectives:
describe and analyze the distribution of data
develop summary statistics
generate and analyze statistical intervals and hypothesis tests to make data-driven decisions
describe the relationship between and among two or more factors or responses
understand issues related to sampling and calculate appropriate sample sizes
use statistical intervals to setting specifications/develop acceptance criteria
use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility
ensure your process is in (statistical) control and capable
Who will benefit:
This seminar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design:
Process Scientist/Engineer
Design Engineer
Product Development Engineer
Regulatory/Compliance Professional
Design Controls Engineer
Six Sigma Green Belt
Six Sigma Black Belt
Continuous Improvement Manager
Agenda:
Day 1 Schedule
Lecture 1:
Basic Statistics
sample versus population
descriptive statistics
describing a distribution of values
Lecture 2:
Intervals
confidence intervals
prediction intervals
tolerance intervals
Lecture 3:
Hypothesis Testing
introducing hypothesis testing
performing means tests
performing normality tests and making non-normal data normal
Lecture 4:
ANOVA
defining analysis of variance and other terminology
discussing assumptions and interpretation
interpreting hypothesis statements for ANOVA
performing one-way ANOVA
performing two-way ANOVA
Day 2 Schedule
Lecture 1:
Regression and ANCOVA
producing scatterplots and performing correlation
performing simple linear regression
performing multiple linear regression
performing ANCOVA
using model diagnostics
Lecture 2:
Applied Statistics
setting specifications
Measurement Systems Analysis (MSA) for assays
stability analysis
introduction to design of experiments (DOE)
process control and capability
presenting results
Speaker:
Heath Rushing
Co-founder and Principal, Adsurgo
Heath Rushing is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications, and long-term training plans in quality and statistics across a variety of industries to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences. As a Quality Engineer at Amgen, he championed statistical principles in every business unit. He designed and delivered a DOE course that immediately became the company standard required at multiple sites. Additionally, he developed and implemented numerous innovative statistical methods advancing corporate risk management, process capability, and validation acceptance criteria. He won the top teaching award out of 54 instructors in the Air Force Academy math department where he taught several semesters and sections of operations research and statistics. Additionally, he designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.
Location: Philadelphia, PA Date: January 5th & 6th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Garden Inn Philadelphia Center City
Address: 1100 Arch Street, Philadelphia, Pennsylvania, 19107, USA
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
Until December 15, Early Bird Price: $1,295.00 from December 16 to January 3, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register now and save $200. (Early Bird)
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/2eqHQWM-Statistics-for-Scientists
Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
↧
University Community Safety and Wellbeing
The ground-breaking Respect. Now. Always. national university student
survey on sexual assault and sexual harassment is a key part of an
initiative by Australian universities to prevent and address these issues.
Universities Australia has asked the Australian Human Rights Commission
to conduct the survey, and is working closely with the Commission to
implement it currently.
There is a clear priority on reducing violence on campus. It is essential
for universities to provide key safety and wellbeing services for students. A
failure to do so risks not only an increase in attrition, but student success
and even student lives.
This conference will provide key strategies to address violence and sexual
assault, mental health and wellbeing issues and how universities can work
collaboratively to provide better support.
↧
Seminar on Verification vs. Validation - Product Process Software and QMS 2017
Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions.
Why should you attend?
This session helps participants:
Understand Verification and Validation, differences and how they work together;
Discuss recent regulatory expectations;
Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;
Determine key "milestones" and "tasks" in a project;
Locate and document key subject "inputs";
Compile "generic" Master and Individual Validation Plans;
Learn the key element of a Product V&V File/Protocol;
Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;
Get a grasp of basic Test Case construction;
Understand sample sizes and their justification;
Learn the key elements of Software V&V expected by the FDA and how to document;
Deal with hardware and software vendors, sales and marketing
Consider a field-tested software V&V documentation "model";
See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.
Who will benefit:
This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation.
The employees who will benefit include:
Senior and middle management and staff
Regulatory Affairs
Quality Assurance or Quality Control Professionals
QA/QC
IT/IS
R&D
Production Management
Manufacturing Engineers
Process Engineers
Software Engineers
Project Managers
Hardware and software vendors, sales and marketing
Any professional tasked with V&V responsibilities
Agenda:
Day 1 Schedule
Lecture 1:
Master Validation Planning and the Master Validation Plan(s)
Lecture 2:
Product, Process / Equipment Hardware V&V
Lecture 3:
Product / Device V&V
Lecture 4:
Software V&V
Lecture 5:
Quality Management System / 21 CFR Part 11 V&V
Lecture 6:
Summary of morning discussion
Lecture 7:
Group activity on the MVPs
Lecture 8:
Review of group activity and Q&A
Day 2 Schedule
Lecture 1:
Software V&V documentation "model"
Lecture 2:
Software V&V protocols - "black box", "white box"
Lecture 3:
Electronic Records and Electronic Signatures (Part 11)
Lecture 4:
Summary of morning discussion
Lecture 5:
Group activity on 1) hardware / equipment, and 2) software V&V protocols
Lecture 6:
Review of group activity and Q&A
Lecture 7:
Course summary discussion
Lecture 8:
Summary of morning discussion
Lecture 9:
Group activity on the MVPs
Lecture 10:
Review of group activity and Q&A
Speaker:
John E Lincoln
Consultant, Medical device and Regulatory affairs,
John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.
Location: Las Vegas, NV Date: January 12th & 13th, 2017 and Time: 09:00 AM to 06:00 PM
Venue: Embassy Suites Convention Center Las Vegas
3600 Paradise Road, Las Vegas, Nevada, 89169, USA
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until December 15, Early Bird Price: $1,295.00 From December 16 to January 10, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/2e4Js9T-Verification-Validation
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
↧
FDA's Two New Draft Guidance on Software and Device Changes and the 510(k) - By AtoZ Compliance
Key Take Away :
This webinar will teach you how to use a series of flowcharts to evaluate whether or not a change to a medical device or to software requires a new draft guidance 510(k) submission, based on the type of medical device changes, and the impact on the safety and effectiveness of the device as used by a person.
Overview :
This webinar is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) submission requirement (premarket notification) for changes to an existing device and/or software integrated with a device.
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a companys decisions are provided.
The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness.
FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:
FDA Labeling
Technology, engineering and performance
Materials
Technology, engineering, performance and materials for in vitro diagnostic devices
The second FDA guidance addresses proposed changes to software used in conjunction with a medical device. The draft includes modifications made to correct software defects, provide patches or updates to code, and provide enhancements or modifications to functionality. Software manufacturers must determine whether any change or modification could potentially and significantly affect the safety or effectiveness of a device.
The first step recommended by FDA is to conduct a risk assessment of the change, including all potential new risks along with known risks for the device. Again, the FDA provides a flowchart to guide software manufacturers through the process of determining whether a 510(k) Device Modifications must be prepared. FDA also provides examples of changes to software, along with an analysis as to why a new 510(k) premarket notification would or would not be needed.
The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k).
The guidance documents also do not address 510(k) submission requirements for remanufacturers of existing devices, such as re-processors of single-use devices.
Why Should You Attend :
You should attend this webinar if you have any role in evaluating changes to medical devices, including those to labelling, technology/engineering/performance, and materials.
You will learn what factors should prompt additional testing, and the type of documentation to prepare for FDA Medical Device & Software Guidance, whether a new 510(k) is required or not.
Areas Covered In This Webinar :
Medical Device changes
Software Application changes for software used in conjunction with medical devices
FDA Guidance Documents
FDA Enforcement
New FDA 510(k) submission
Flowcharts for decision-making
Learning Objectives :
Know the key aspects of the two FDA draft guidance documents
Specific recommendations for how to assess the level of risk associated with the product and the change to it
Examples the FDA uses to give guidance on what devices and/or software changes require a 501(k) and what ones do not
Who Will Benefit :
Manufacturing Managers and Analysts
Device and Software Engineers
Compliance and Audit Managers
Information Technology Analysts
Information Technology Developers and Testers
QC/ QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/ Subject Matter Experts
Business System/ Application Testers
For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/medical-devices/fda-new-draft-guidance-on-software-device-changes-510k/carolyn-troiano/300164#speakerBreaf
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509
Level:
Intermediate
Speakers Profile :
Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDAs electronic record/electronic signature regulation.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMIs Educational Fund as a project management instructor for non-profit organizations.
↧
↧
RSM Aesthetics 9
Now in its 9th year this international conference provides a forum for new advances in the science and practice of medical, surgical, laser and device aesthetics to be presented and discussed in a collegiate atmosphere.
The conference features international speakers, live demonstrations and case reports on new and novel material concerning treatments, complications and new advances in technology and aesthetic practice.
Alongside the main scientific conference delegates will also have the opportunity to attend optional workshops, which must be booked in advance. Optional workshops include:
- Chemical peels
- Botulinum for beginners
- Mesotherapy
- Filler
- Threads
- Revalidation
Early bird rates will be available until Thursday 8 December 2016, book now to save up to GBP 80.
Prices:
Early bird RSM member from: GBP 55
Early bird non member from: GBP 75
RSM member from: GBP 95
Non member from: GBP 115
Optional workshop: GBP 65
Optional dinner: GBP 65
Speakers: Christopher Rowland Payne, Gun-Young Ahn, Pierre Andre, Vladlena Avernia, Hugues Cartier, Eckart Haneke, Andreas Katsambas, Han-Jin Swon, Luigi Polla, Alessio Redaelli, Wolfgang Redka-Swoboda, Gerhard Sattler, Alain Tenenbaum, Patrick Treacy, Ines Verner, Uliana Gout
Time: 8:30 am - 6:30 pm
↧
The 3rd International Neonatology Association Conference (INAC 2017)
The 3rd International Neonatology Association Conference (INAC 2017) provides a unique platform to discuss a wide range of topics related to neonatology. An international audience will attend and presentations will be given by renowned professionals. The Scientific Committee has developed a programme with topics, such as Nutritional Management and the Importance of Human Milk, New Advances in Fetal Evaluation and Testing, Maternal-Fetal Medicine, High Tech Neonatology, Neonatal Infections Congenital, Early and Late Onset, Neonatal Radiology, Neonatal Nephrology, Ethical Issues and Neonatology in Future, Neonatal Hematology, Neonatal Cardiology, Neurology of the Newborn, Global Neonatal Mortality, Pharmacology and Therapeutics, Birth Defects, Resuscitation and more.
Don't miss the opportunity to join peers and key opinion leaders in Lyon, France, 7-9 July, 2017. Get a head start, visit INAC 2017 website.
URL:
Facebook: https://go.evvnt.com/73941-1
Prices:
Participants: EUR 480
Participants from Developing Countries: EUR 375
Residents, Nurses, Midwives: EUR 320
Students: EUR 250
Accompanying Persons (for reception only): EUR 60
Speakers: Jean-Charles Picaud, Avroy Fanaroff, Lucky Jain, Ashok Gupta, Francis Mimouni, Manuel Sanchez Luna, Mohamed Bassiouny, Lex Doyle, Chinyere Ezeaka, Ajay Gambir, Amit Gupta, Emilio Hernandez, Ariadne Malamitsi-Puchner, Dara Paro Panjan, Arun Pramanik, Jose Salazar, Mike Segall, Raid Umran, Sithembiso Velaphi, Max Vento, Michael Weindling
Time: 1:00 pm - 4:00 pm
↧
2017 Conference on Applying ISO14971 and IEC62304 - A guide to practical Risk Managemen
Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.
Who Will Benefit:
The course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.
The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.
The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner's perspective.
Following personnel will benefit from the course:
Senior quality managers
Quality professionals
Regulatory professionals
Compliance professionals
Project managers
Design engineers
Software engineers
Process owners
Quality engineers
Quality auditors
Medical affairs
Legal Professionals
Agenda:
Day 1 Schedule:
Lecture 1: Introduction into Risk Management and Quality System Integration
Why risk management?
o Historical perspective
o International regulatory / statutory requirements
Risk Management Lifecycle and stakeholders
o Over-reaching concept
o Integration into ISO13485
o Lifecycle steps
Risk Management Benefits
o Liability issues
o Streamlining product development
o Improving product safety and quality
How to Implement Risk Management into ISO13485
o SOP framework
o Planning and execution
o Monitoring and control
Lecture 2: Risk Management to ISO 14971:2012
o Risk Management Planning
o Risk Management Life Cycle
o Hazard Identification
§ Hazard Domains
§ Hazard Latency Issues
§ Risk Rating Methods
o Initial (unmitigated) Risk Assessment
o Mitigation Strategies and Priorities
o Mitigation Architectures
§ Alarm Systems as Mitigations
§ Risk Control Bundles
o Post Mitigation Risk
o Residual Risk
§ Safety Integrity Levels
o European special requirements (Z-Annexes)
o Safety Requirements
o Hazard Mitigation Traceability
o Verification Planning
o Architectures, Redundancy and Diversity
o Failure Mode and Effect Analysis
o Tips and Tricks
o Q&A
Day 2 Schedule:
Lecture 1: Usability and Risk Management
Use errors as hazard source
User intervention as hazard mitigation
Usability engineering lifecycle
Application specification
Usability Specification
Frequently used functions / primary operating functions
Usability verification / validation
Upcoming changes IEC62366:2014
Lecture 2: Software Risk Management (IEC62304 / FDA software reviewers' guidance):
Critical Software Issues
Software Hazard Mitigation Strategies
Software Item, Unit and System Definition
Software Failures as Hazard Sources
Software Requirements and Design Specification
Software Tools and Development Environment
Lecture 3: Software Risk Management (IEC62304 / FDA software reviewers' guidance):
Software Unit and Integration Testing
Real-Time System Challenges
Software Verification and Validation
Mitigation Traceability and Effectiveness
Software Maintenance and Configuration Control
Software Risk Management Process integration into ISO14971
Legacy Software issues
FDA documentation requirements
Upcoming changes in IEC62304:2014
Tips and Tricks
Lecture 4: Safety / Assurance case
Safety classes
o Basic Safety / Environment
o Essential performance
Documentation of Basic Safety
o Electrical Safety
o Mechanical Safety
o EMC / RFI safety
o Safety margins
Documentation of essential performance
o What is essential performance?
o Device architectures and mitigation allocation
o Device specific mitigations
o Software mitigations
External safety
o User intervention and alarms
o Organizational measures
o Levels of protection concept
Verification of safety properties
o Type testing
o Sample testing
o Software verification testing
o Inspections
o Analyses
Assurance case vs. Risk Management Report
o General safety and hazard avoidance
o Device / application specific issues
Tips and Tricks
Q&A
Speaker:
Markus Weber
Principal Consultant, System Safety Inc.
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.
Location: Boston, MA Date: January 19th & 20th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Embassy Suites Boston Logan Airport
Address: 207 Porter Street Boston, MA 02128
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until December 15, Early Bird Price: $1,295.00 From December 16 to January 17, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/2eXBzCw-ISO14971-and-IEC62304
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
↧
More Pages to Explore .....
