Quantcast
Channel: Health and Medicine
Viewing all 8759 articles
Browse latest View live

Fibromyalgia: Clinical Review and Strategies for Managing Your Patients

0
0
Fibromyalgia: Clinical Review and Strategies for Managing Your Patients will present up-to-date information as well as contemporary approaches/strategies for the treatment of fibromyalgia. The program will cover the many facets of fibromyalgia, with expert faculty presenting evidence-based information and emerging practical clinical approaches. TARGET AUDIENCE This course is designed for physicians, nurse practitioners, and physician assistants who work in the fields of internal medicine, family medicine, physical medicine and rehabilitation, or psychiatry/psychology who provide care for patients with fibromyalgia. LEARNING OBJECTIVES Summarize recent updates, clinical studies, and guidelines that impact the understanding and treatment of fibromyalgia. Describe the indications and major adverse effects of the commonly used medications for fibromyalgia. Recognize common clinical pearls in fibromyalgia. Review both medication and non-medication treatment options for fibromyalgia. Summarize the underlying process of central sensitization. Time: 7:30 am - 12:30 pm Prices: MD, PhD, DO, PharmD: USD 350 Fellow, Resident, RN, NP, PA: USD 325

HIPAA Enforcement Activity — Learn What NOT To Do and Avoid Penalties

0
0
Product Format: Live Audio Conference Presenter(s): Jim Sheldon-Dean Conference Date: Tue, Apr 11, 2017 Aired Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT Length: 60 minutes Price: $249.00 Join expert speaker Jim Sheldon-Dean in this session, as he reviews the HIPAA enforcement actions that have taken place, and examines why the enforcement took place, and what could have been done to prevent the incident. For Registration, visit http://bit.ly/2mhppbG Special Offer: Use code EVENT25 to get $25 discount. Not able to attend the audio session? We will provide you with a replay of the session, or you can request a DVD recording. For any queries feel free to contact Customer Service at 1-866-458-2965 or e-mail at customerservice@audioeducator.com.

Hematologic Cancers: An Introduction

0
0
Hematologic Cancer Course for pharmaceutical / life science personnel. Learn face-to-face from leading specialist physicians. Gain information fast. Discuss with experts. Get your questions answered. Hematologic Cancers training held over two days. Developed specifically to support the education needs of the pharmaceutical and other associated industry personnel. Provides a comprehensive review of the hematological system and an overview on the spectrum of hematologic cancers. This hematologic cancers training includes: - Pathophysiology of hematological malignancies such as leukemias, lymphomas and myeloma - Common treatments and management of these hematological malignancies - Challenges these treatments present to patients - Review of the issues and complications of bone marrow and stem cell transplant Topics include: - The formation and maturation of blood cells - Classification and epidemiology of hematological malignancies - Presentations, diagnosis and staging - Chemotherapy and irradiation - Clinical trial issues Small class size. Inspiring, interactive learning environment. Ample opportunity for discussion and to have your questions answered by the expert faculty. Training takes place in a Newark, New Jersey venue. The location is easily accessible for travel worldwide. Group registration rates available. Get in touch for details. URL: Website: https://go.evvnt.com/107072-1 Price Individual: USD 4995 Artists / Speakers: Dennis Cooper MD Yale, Louis F Diehl MD Sidney Kimmel CCC, Carol Ann Huff MD Sidney Kimmel CCC, Mark Levis MD Sidney Kimmel CCC, Douglas Smith MD Sidney Kimmel CCC Tuesday October 24, 2017 at 8:45 am (ends Wednesday October 25, 2017 at 3:45 pm)

Ankle and Feet Coding - Putting the Right Foot Forward

0
0
Product Format: Live Audio Conference Presenter(s): Margie Scalley Vaught, CPC, CPC-H, CPC-I, CCS-P, PCE, MCS-P, ACS-EM, ACS-OR Conference Date: Tue, Apr 11, 2017 Aired Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT Length: 60 minutes Price: $197.00 If you are a podiatry coder, you need to be an expert in coding for fracture care and surgical repair in ankle, foot and toe segments. Join this audio session with expert speaker Margie S. Vaught to go through the basic anatomy and how it relates to the different surgical procedures in the ankle/foot/toe segments. For Registration, visit http://bit.ly/2na4iF1 Special Offer: Use code EVENT25 to get $25 discount. Not able to attend the audio session? We will provide you with a replay of the session, or you can request a DVD recording. For any queries feel free to contact Customer Service at 1-866-458-2965 or e-mail at customerservice@audioeducator.com.

9th International Conference on Antimicrobial Agents in Veterinary Medicine

0
0
This forthcoming conference follows the success of the past eight AAVM held in Helsinki, Ottawa, Orlando, Prague, Tel Aviv, Washington DC, Berlin and Budapest. This conference has emerged as one of the leading meetings in its field, which provides a very intensive program and encourages communication among the attendees. Infectious diseases are very common in veterinary medicine and antimicrobial agents have a predominant role in veterinary therapeutics both in farm and companion animals. Antimicrobial use is still under the spotlight for the potential of antimicrobial resistance and human health risks. Valid alternatives to these drugs are still not routinely available and the veterinary medicine has to deal with their use and with a more modern and updated approach in the therapy. These aspects and many others, such as, pharmacokinetics, pharmacodynamics, PK/PD modelling, antimicrobial resistance, residues, clinical trials, new antimicrobial molecules, etc. will stay in the forefront of the topics of the AAVM programs and will be discussed in depth with the participation of speakers of high repute as well as attendees. Veterinary use of antimicrobials has been increasingly criticized, especially for the potential of resistance transfer from farm animals to humans. Simultaneously, the ever decreasing introduction of new antimicrobial molecules has also limited the number of useful therapeutic agents. Modern approaches for infection reduction in intensive rearing farms are in progress. New ideas of alternatives and 'greener' options in the treatment of infectious diseases are under investigation. What the potentials are will also be addressed in the upcoming AAVM meeting. Time: 6:00 am to 6:00 pm URL: Booking: https://go.evvnt.com/106847-1 Price: Participant fee starts from: EUR 600 Speakers: Prof. Petra P. Cagnardi, Prof. Stefan Soback

BioBanking 2017

0
0
SMi's 7th annual conference on Biobanking will bring together Europe’s leading biorepositories, regulatory bodies + scientific pioneers to strengthen knowledge in biosample management as well as explore future advances in areas such as mobile bio-banking and cloud based sample management. Understanding the ethical and regulatory framework as well as the impact of the General Data Protection Regulation (GDPR) on collaborative science in Europe will be a major focus. Plus, don’t miss keynote addresses from a selection of European biobanks currently adding value to clinical research through successful biobanking strategies including the European Sperm Bank, UK Biobank, UCL Baby Biobank, Auria Biobank and more. Exclusive updates from the European Commission and NIBSC-MHRA, will be just some of the event highlights for 2017. Join us this June to stay at the forefront of Biobanking developments in the 21st Century and address relevant and critical issues on how to improve your biobanking practice. Key Speakers include: -Brian Thomson, Dir and Clinical Lead for 100K Genome Project, Nottingham Health Science Biobank -Heli Salminen-Mankonen, Dir, Auria Biobank -Emanuele Barbarossa, Legal Adviser/Policy Analyst, European Commission -Arndt Schmitz, Senior Translational Assay Technology Expert, Research Biobank, Bayer -Kris Spreckley, BD Dir, UK Biobank/UK Biocentre -Peadar Mac Gabhann, Dir, Biostor Ireland -Annemette Arndal-Lauritzen, CEO, European Sperm Bank -Saakje Mulder, CEO, LifelinesNL -Sarah Gilbert, Principal Scientist, NIBSC–MHRA -Vincent von Walcke-Wulffen, CEO, BioKryo NEW FOR 2017 -Spotlight session on 'digital biobanks' -The impact of the GDPR -CASE STUDIES: Samples for research in Poverty Related Diseases and Cloud-based sample management of multi-centre clinical trial in corneal transplantation -Challenges and opportunities in running a national, multicentre, disease-specific biobank Early bird rates available online Time: 8:30 am - 5:00 pm Price: Conference + workshop: GBP 2098 Conference: GBP 1499

AHRMM17 - The Leading Healthcare Supply Chain Conference and Exhibition

0
0
Held every summer, this leading event for the healthcare supply chain field brings together more than 2,000 hospital supply chain, materials management, and C-suite executives for four days of unparalleled networking, exhibitor interactions, product presentations and practical education offered at all career levels. Whether it's meeting speakers, attendees, and exhibitors at the Welcome Reception, or picking the brains of some of the supply chain's brightest minds during Lunch & Learns, AHRMM17 provides ample opportunities to catch up with colleagues and make new connections that can be the start of long-lasting professional relationships. The conference features more than 50 learning labs presented by over 100 supply chain’s thought leaders and innovators from across a broad spectrum of healthcare organizations so you can capture a year's worth of healthcare supply chain latest trends and best practices in just a few short days. The learning labs are organized in the following eight tracks: 1. Clinical Resource Management/Value Analysis 2. Logistics 3. Procure to Pay 4. Professional Development 5. Strategic Planning 6. Strategic Sourcing 7. Technology, Informatics 8. UDI Adoption The two-day AHRMM Exhibition allows you to take an exclusive look at the latest technology and advances in healthcare while making business connections with medical suppliers and GPOs. With more than 200 exhibiting companies and 6.5 dedicated exhibit hours, you can find innovative, high quality medical products and related business services to improve care quality and patient safety in your healthcare organization. AHRMM17 exhibitor categories: Asset Management Capital Equipment Distribution Environmentally Preferred Products Equipment Maintenance/Rental Group Purchasing Organizations IT/Software Laboratory Medical/Surgical Products Orthopedics Safety Shelving/Storage Transportation For sponsorship/exhibition enquiries, please contact ahrmm@aha.org. Price Early Bird Member (before May 1): USD 700 Early Bird Non-Member (before May 1) : USD 900 Regular Member (after May 1): USD 900 Regular Non-Member (after May 1): USD 1100 Speakers: Mike Schiller, Rob Waldo Waldman, Jim Morris, Karen Conway Time: on Sunday July 23, 2017 at 8:00 am (ends Wednesday July 26, 2017 at 12:00 pm)

Hospital Management Asia 2017

0
0
HMA offers hospital and healthcare managers the opportunity to learn specific tools and techniques to do their jobs better, in an environment of quality learning and networking with peers. Benefits of Hospital Management Asia: -Successful healthcare strategies -Proven patient-care and risk management techniques -Quality standard tips -Hospital management trends and more! Tickets: https://go.evvnt.com/106851-0 Price: Early Bird rate (1-2 Overseas delegates) *ends 9 June: USD725 Regular rate (1-2 Overseas Delegates) * ends 28 July: USD830 Late rate (1-2 Overseas delegates) *ends 24 August: USD945 Time: 8:00 am to 6:00 pm

41st European Congress of Cytology

0
0
The European Federation of Cytology Societies (EFCS) and the Spanish Society of Cytology (SEC), invite you to the 41st European Congress of Cytology, to be held in Madrid, Spain, from 10-14th of June 2018. This ECC meeting intends to turn into a fruitful and stimulating encounter for professionals in the field of cytology, from all Europe and beyond. It will be an opportunity to share and communicate scientific advances, as well as to meet friends in a lively city with a well-known cultural and artistic ensemble. The scientific programme will address traditional as well as challenging innovative aspects of cytopathology and interactive methodologies. It will include symposia covering morphology, new disease classifications, reporting guidelines, cervical cancer screening programmes, HPV assessment, molecular techniques and targeted therapies, quality assurance, technical and formative aspects in cytotechnology and cytopathology. It will also feature slide seminars and practical microscopic and non-microscopic workshops, video microscopy tutorials and roundtable discussions to promote debates. This program, together with the information shared through poster and platform presentations, will help us to update cytopathologists and cytotechnologists on the current practice of cytopathology. Language simultaneous translation will be available for Spanish-speaking attendees. The venue, Hotel Melia Castilla, one of the largest hotels in Europe, is strategically located in the city center with excellent access to and from any part of the city. It is placed next to Paseo de la Castellana, the Real Madrid football stadium and the Golden Mile. Madrid, a sunny and renowned cultural city, hosts some of the best museums of the continent and is worldwide known for its gastronomy and its vibrant nightlife. Nearby historical towns (Toledo, Segovia, Avila, El Escorial) will complete your stay. Welcome to the 41st ECC meeting! Time: 8:00 am to 9:00 pm URLs: Tickets: https://go.evvnt.com/106875-1 Brochure: https://go.evvnt.com/106875-2 Booking: https://go.evvnt.com/106875-3 Inquiries: https://go.evvnt.com/106875-4 Price: Registration Opens - Monday 7th November 2017: EUR 0 Speakers: Edmund S. Cibas, Philippe Vielh, Beatrix Cochand-Priollet, Fernando Schmitt, Asash Chandra, Lukas Bubendorf, Luigi Di Bonito, Luigi Di Bonito, Paul Cross, Amanda Herbert, Fernando Lopez-Rios, Silvia de Sanjose, Giancarlo Troncone, Pio Zeppa, Ritu Nayar, Barbara Centeno, Sabine Pomplum, Roberto Dina, Miguel Angel Perez-Machado, Allan Wilson, Sinchita Roy-Chowdhuri, Karin Denton, Enrique de Alava, Jose Palacios, JuliAn Sanz, William C. Faquin, John H. F. Smith, Robert Y. Osamura

Oncology Clinical Experience

0
0
Healthcare's Oncology Clinical Experience is an opportunity to gain a thorough understanding of oncology and cancer treatment. It offers real and complete knowledge from a drug development, clinical research and clinical perspectives. Cutting-edge information is delivered by practising clinical specialists. Theory is clearly explained and illustrated by visits to departments. You meet the healthcare professionals involved in caring for this patient group, with opportunity to ask questions and to interact with patients. Oncology Clinical Experience Programme provides participants with an overview of the spectrum of malignant disease. The manifestation, presentation, investigation and management of a range of common solid tumour types (breast, lung, colorectal, gastrointestinal, melanoma, renal) are reviewed. Clinicians active in these areas examine patient management throughout the process. Imaging techniques and radiotherapy treatment are explained with visits to these departments. The context of cancer care is reviewed, including the epidemiology of cancer and factors affecting treatment choices and prescribers' decision-making. This is your chance to fully understand oncology from a clinical perspective and gain knowledge to discuss oncology credibly. Information at: http://healthcare-ed.com/course/oncology-clinical-experience/ Who Should Attend? Courses will benefit medical and non-medical staff within the pharmaceutical, biotechnology, medical device and associated healthcare industries. This course is suitable for clinical research, medical information, regulatory affairs, patent attorney, branding, biometrics, strategic marketing and personnel in similar roles. Small class size. Informative, engaging, interactive learning. Ample opportunity for discussion and to have questions answered. Training is hospital based in Leeds, UK. The location is easily accessible for travel worldwide. Limited places due to unique location. Discounts for groups Website: https://go.evvnt.com/107435-1 Price: Individual: GBP 3940 Speakers: Professor Chris Twelves, St James’s University Hospital, Leeds, UK Time: 9:00 am to 12:30 pm

International Conference on Applied Science, Healthcare Management ( ICASHM 2017 )

0
0
ICASHM 2017 is the premier community forum concerned with the application of computer science principles, information science and informatics principles, information technology, and communication technology to address problems and support research in healthcare, medicine, life science, public health, and everyday wellness.

International Conference on Medical Science, Biological Engineering and Computing ( ICMSBEC 2017 )

0
0
The main conference will be held over two days; up to three parallel rooms will run simultaneously bringing together world experts in Medical Science, Biological Engineering and computing to exploring the latest updates in medicine, Biological Engineering and computing a variety of other topics. In addition, a wide range of Masterclasses and Workshops are planned at the ICMSBEC 2017 to the Conference to give you an excellent excuse for an extended visit to California

Guidelines for New FDA Transfer of Analytical Methods - 2017

0
0
Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Areas Covered in the Session: Four approaches for analytical method transfer and testing Responsibilities of the transferring and receiving laboratory Developing a transfer plan and a pre-approval protocol Who Will Benefit: Analysts Lab Supervisors and Managers QA Managers and Personnel Consultants Teachers Speaker Profile: Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com

Root Cause Analysis to Meet FDA Expectations - 2017

0
0
Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Why should you Attend: A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm. Areas Covered in the Session: Regulatory "Hot Buttons" The 4 Basic Steps to Problem Solving A Suggested Investigation Template Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Speaker Profile: John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, 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 described in peer-reviewed technical articles, and workshops, world wide. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com

17th Global Ophthalmology, Optometry and Glaucoma Conference

0
0
Conference Series LLC welcomes participants from all over the globe to attend 17th Global Ophthalmology, Optometry and Glaucoma Conference during November 2-4, 2017 at Bangkok, Thailand which includes prompt keynote presentations, Oral talks, Poster presentations and Exhibitions. Glaucoma 2017 is a global platform to discuss and learn about Ophthalmological Associated Diseases and their Treatment. Ophthalmology is the branch of medicine that deals with the anatomy, physiology and diseases of the eye. An ophthalmologist is a specialist in medical and surgical eye problems. Since ophthalmologists perform operations on eyes, they are both surgical and medical specialists. A multitude of diseases, vision defects and conditions can be diagnosed from the eye namely cataract, myopia, hyperopia, astigmatism and conjunctivitis. This annual gathering of Ophthalmologists and Optometrists at Dubai aims to provide an insight about the latest advancement and treatment modalities in the field of ophthalmology and other associated prospects.

4th Immunogenicity

0
0
SMi is thrilled to present the return of its 4th annual Immunogenicity conference and exhibition, taking place in London on the 12th – 13th June 2017. The immunogenicity market has seen considerable progression over recent years, with innovative developments apparent in predicting and controlling immunogenicity. However the industry is still subject to complex hurdles and challenges. This year’s conference will provide attendees with a thorough understanding of the continued need for harmonisation across risk assessments and data reporting, as well as guidance for clinical trial design. Speakers will offer deep exploration of the regulations surrounding immunogenicity testing, from the UK, Europe, and USA, giving exclusive opportunity for discussion and debate with key regulatory experts. With focus on delivering true value for all delegates in attendance, Immunogenicity 2017 will identify and solve key challenges for industry experts. Insight into aggregations, next generation biologics, novel assays, humanisation of bio-therapeutics, and improvements to accurate risk assessment will be complemented by high level case studies. CONFERENCE HIGHLIGHTS: . Guidance on UK, EU and USA regulations surrounding immunogenicity and best practice risk assessment . Targeted focus on immunogenicity; identifying, addressing and removing challenges to industry . Highlight best practice risk assessment and mitigation through high level case studies . Explore novel and innovative approaches to reducing immunogenicity . Spotlight on new technology; Humanising proteins and new biotherapeutic solutions . Personalising treatments with next generation biologic drugs Time: 8:30 am to 4:30 pm URLs: Booking: https://go.evvnt.com/105011-0 Price: Book by 31 March: GBP 1199 Book By 28 April: GBP 1299 Book By 31 May: GBP 1399 Standard: GBP 1499 Speakers: Regeneron, EpiVax Inc., Boehringer Ingelheim, ProImmune Ltd, UCB, Roche, Selecta Biosciences, Novartis, NIBSC, MHRA, EpiVax Inc, AbbVie, INSERM, Merck and many more

8th Aggregate Spend and Sunshine Act Conference 2017

0
0
Unlock the value of transparent and efficient data reporting to improve the operation of your organization The Physician Payments Sunshine Act is intended to advance the life sciences industry's standard of transparency, yet the ambiguity of current regulatory principles continues to puzzle compliance and reporting professionals, leaving them with more questions than solutions. In addition to these monitoring issues, the actual collection of aggregate data is extremely taxing for departments across organizations, which complicate even the most effortless tasks. For nearly a decade, the Aggregate Spend and Sunshine Act Conference has proven to be the industry's leading educational event where compliance and reporting professionals convene to discuss past submissions and upcoming changes in order to better prepare for the future. Through interactive discussions and expert presentations, this advanced conference will provide you with the tools needed to leverage your data analytics and elevate your daily operations. Top Five Reasons to Attend 1. Uncover ways to optimize your organization's daily operations using aggregate spend data required by the Sunshine Act 2. Comply with new CMS documentation guidelines surrounding aggregate spend reporting 3. Learn how to effectively communicate with HCPs across national and global data reporting landscapes 4. Consider frameworks for conducting internal audits designed to measure success 5. Discuss best practices for leveraging your data analytics to assess compliance risk URLs: Booking: https://go.evvnt.com/107738-1 Brochure: https://go.evvnt.com/107738-2 Price Early Bird Pricing: (Register by April 28, 2017): USD 1895 Standard Pricing: (Register by June 14, 2017): USD 2095 Onsite Pricing: USD 2195 Speakers: Donna White, Richard Velardi, Avi Spira, Daniel Smout, Helen Park, Michael Pace, Amie Phillips Pablo, Michael O'Connor, Leo Otero, Michael Hunn, Derek Devgun, Gretchen Reyes Cseplo, Melissa Blaco, Ishita Arora Time: 8:00 am to 5:00 pm

Haematological Malignancies

0
0
Haematological Malignancies, gain a kick-start to knowledge. Learn from experts over two days. Short course delivered face-to-face and developed to support the education needs of the pharmaceutical and associated industry personnel. Provides an overview of haemopoisis and explains the spectrum of haematological cancers. The expert team helps you better understand the pathophysiology of haematological malignancies, such as leukaemias, lymphomas and myeloma, and their treatment and management. They will review with you, the issues and complications of bone marrow and stem cell transplant and consider matters relating to clinical trial issues including ethical considerations. Case studies, quizzes and open discussion form an integral part of the programme. Topics include: - Acute Leukaemias - Stem Cell Transplant - Chronic Myeloid Leukaemia (CML) - Chronic Lymphocytic Leukaemia (CLL) - The Lymphomas - Hodgkins and Non-Hodgkins - Myeloma - Myelodysplasia and Myeloproliferation Small class size. Inspiring, interactive learning environment. Ample opportunity for discussion and to have your questions answered by an expert faculty. Training takes place in a London, UK venue. The location is easily accessible for travel worldwide. Group registration rates available. Get in touch for details. Website: https://go.evvnt.com/107429-1 Price: Individual: GBP 2880 Speakers: Dr Mark Drummond Beatson West Scotland Cancer Centre Glasgow UK, Dr George Follows Addenbrooke’s Hospital Cambridge UK, Professor Graham Jackson Freeman Hospital Newcastle-Upon-Tyne UK, Dr Mike Potter The Royal Marsden Hospital UK, Professor Simon Rule Derriford Hospital Plymouth, UK Time: 8:45 am to 4:15 pm

European Antibody Congress

0
0
Our mission, for every European Antibody Congress, is to bring you the very best speakers from big pharma, biotechs, academia and technology innovators to discuss with you the most exciting breakthroughs when it comes to the discovery and development of antibodies. Whether that's the newest format of a cancer killing ADC, the most advanced screening technology for mAbs, or the clinical development of a bispecific with promises to treat Alzheimer's disease, we want to give you access to all of this to grow your knowledge, grow your business, and grow your connections. Prices: Standard early bird price (before 31st March): EUR 1930, Academic early bird price (before 31st March): EUR 965. Speakers: Alain Beck, Senior Director, NBEs Analytical Chemistry, Pierre Fabre, Associate Editor, mAbs, Alain Vertes, Managing Director, NxR Biotechnologies, Alexey Rak, Head of Bio Structure and Biophysics, Sanofi RandD, Alfonso Quintas, Head of Clinical Research, Cell Therapies Unit, GSK, André Choulika, CEO, Cellectis, Andrea Gonzalez-Munoz, Research Associate, MedImmune, Andreas Plückthun, Professor of Biochemistry, Director, Department of Biochemistry, University of Zurich, Annelise Vuidepot, VP, Head of Oncology Pipeline and Research, Immunocore, Carsten Kranz, Drug Metabolism and Pharmacokinetics, Novartis Pharma AG, Christian Klein, Head of Oncology Programs, Roche, Christian Rommel, Global Head of Oncology Discovery, Roche, Christoph Merten, Group Leader Microfluidics, European Molecular Biology Laboratory, Christoph Rader, Associate Professor, Department of Immunology and Microbiology, The Scripps Research Institute, Dario Neri, Founder, Philogen; Professor of Chemistry and Applied Biology, Swiss Federal Institute of Technology Zurich, David Brindley, Senior Research Fellow in Healthcare Translation, Department of Paediatrics, University of Oxford, David Gilham, Vice President of Research and Development, Celyad, David Meininger, Chief Business Officer, Trianni, Feng Wang, Principal Investigator, CaliBR, Frank Walsh, CEO, Ossianix, Gregory Winter, Master of Trinity, Cambridge University, Founder and Co-Director, Bicycle Therapeutics Time: 9:00 am to 5:00 pm

Audit Like the FDA - What you need to know for a truly effective internal audit program

0
0
Course "Audit like the FDA - What you need to know for a truly effective internal audit program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks. In this seminar, we will discuss: • Regulatory Expectations • How to develop and implement an efficient and effective audit program • Common problems • Red-flags that your program is not effective • Risk Analysis techniques • Audit Program Structure • The auditing process - steps and tools • Documentation and communication Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement Why should you attend: Continuous Improvement starts with awareness of issues and opportunities. And without an effective audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways to reduce compliance and quality risk. Learning Objectives: Using lecture, interactive discussion, and exercises, this seminar will provide tools and techniques for you to develop or improve your audit program. Students will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference. This 2-day seminar will cover the following areas: • Using a structured program to identify areas of risk leading to an effective audit strategy. • How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review. • How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues. • How a culture of quality and compliance can encourage clear and transparent communication of risk. • How to prioritize, resource, and implement corrective actions. • Techniques for monitoring and communicating risk and improvement over time. • How to identify residual risk. • Signs that your company culture is taking unnecessary compliance or quality risk. • How to ensure management gets valuable information from your audit program. • Tools for documenting audit observations and managing corrective and preventive actions. • Roles and responsibilities. Who will benefit: • Quality Systems Specialists • Document Control Specialists • Quality and Compliance Specialists • Auditors • Internal Auditors • Supplier Auditors • Auditor Managers • Supplier Auditors • CAPA Specialists • Quality/Compliance managers or directors for Medical Device companies Agenda: Day 1 Schedule Lecture 1: Overview Lecture 2: Introductions Lecture 3: Regulatory expectations Lecture 4: Quality Systems requirements for medical devices Lecture 5: Types and goals of audits Lecture 6: Creating a program • Goals • Risk Analysis • Audit schedule • Oversight, communication, monitoring, and escalation Lecture 7: Linkages in your Quality System • CAPA • Metrics and monitoring • Management Review • What the FDA can look at • Record keeping and documentation Lecture 8: Auditor qualifications and skills Day 2 Schedule Lecture 1: The auditing process • Preparation • Planning • Conducting • Interviewing techniques • Good documentation • Following-up • Monitoring progress Lecture 2: Focus on Supplier Auditing Lecture 3: Red Flags and Warning Signs Lecture 4: Best Practices Speaker: Susanne Manz Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc. Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at industry leaders like GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world conducting audits and helping companies to understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance. Location: Boston, MA Date: May 4th & 5th, 2017and Time: 9:00 AM to 6:00 PM Venue: Embassy Suites Boston Logan Airport Address: Embassy Suites Boston Logan Airport 207 Porter Street Boston, MA 02128 Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until March 20, Early Bird Price: $1,295.00 from March 21 to May 02, 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://www.globalcompliancepanel.com/control/globalseminars/~product_id=900854SEMINAR?channel=worldconferencecalendar_may_2017_SEO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel
Viewing all 8759 articles
Browse latest View live




Latest Images