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The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
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Webinar Training Pass
Real-World Serialization in Life Sciences
107 minutes
Recorded on: June 20, 2018
Description: Pharmaceutical serialization expert Bill Fletcher discusses emerging trends in serializing drug products, track and trace systems and FDA and global regulation. He covers:
- Child-to-parent aggregation;
- Complexities of the Drug Supply Chain Security Act;
- Traceability based on third-party logistics; and
- Implementing Electronic Product Code Information Services.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Bill Fletcher, Managing Partner, Pharma Logic Solutions LLC
Recorded on: June 14, 2018
Description: Quality systems expert Dan O’Leary explains the process of setting and measuring quality objectives to meet regulatory requirements. He discusses:
- Methods an FDA Investigator uses to verify compliance;
- Additional requirements from ISO 13485:2016;
- A description of the three types of metrics; and
- How to use Excel to develop a graphical approach to the metrics.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: June 13, 2018
Description: Acting Associate Director for Regulatory Affairs Tamy Kim explains the Oncology Center of Excellence mission to expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer. She discusses:
- The center’s structure, including where it sits within the agency and how it interacts with other centers;
- Nuances of the regulatory role, such as the formation of clinical review teams for oncology products;
- Elements of OCE research; and
- Examples of OCE outreach, including interactions with professional societies and patient or advocacy groups.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tamy Kim, Acting Associate Director for Regulatory Affairs in the Oncology Center of Excellence
Recorded on: June 7, 2018
Description: Attorneys Gilliam Russell and Heather Banuelos discuss FDA and FTC trends in regulating advertising and promotion of medical products. They cover:
- Key focus areas and emerging trends;
- Risk disclosure;
- How such elements as music selection, pacing and distracting visuals can result in an enforcement letter; and
- FTC’s increasing focus on transparency as it bears on novel promotional strategies.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Gillian M. Russell, Counsel, and Heather Banuelos, Counsel, King & Spalding
Appendix M of the NIH Guidelines
47 minutes
Recorded on: June 5, 2018
Description: Clinical research expert Daniel Kavanagh discusses registration and reporting requirements for gene therapy research under the recently revised NIH guidelines. He covers:
- NIH reporting compliance;
- The Office of Science Policy registration process; and
- Progress and safety reporting requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Daniel Kavanagh, Senior Director of Biosafety and Gene Therapy, WCG Biosafety
Recorded on: May 31, 2018
Description: Former FDA compliance officials Cynthia Schnedar and Howard Sklamberg discuss the Center for Drug Evaluation and Research’s plan for restructuring inspection and application review operations. Topics include:
- The new tone of interactions when approaching the agency on specific inspection and evaluation topics;
- What to expect from the FDA in conducting inspections and communicating results you need ASAP;
- New ways in which you’ll be able to encourage the FDA to meet commitments; and
- Difficulties facing the agency in implementing its new concept of operations.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Cynthia Schnedar, Executive VP-Regulatory Compliance, Greenleaf Health LLC; and Howard Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP
Recorded on: May 30, 2018
Description: Patient recruitment expert Steven Pyffer discusses ways to reach potential research subjects through both tradition and digital avenues. He covers:
- Insight on the factors that determine the actual outreach cost of a randomized patient;
- Ways to reduce patient outreach cost; and
- Improved expectations to patient outreach performance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Pyffer, Senior Director of Patient Outreach, ThreeWire
Start Your Quality 4.0 Journey Today
25 minutes
Recorded on: May 24, 2018
Description: Strategic positioning expert Daniela Jansen discusses the all-digital solution known as “Quality 4.0.” She covers:
- Factors, processes and technologies to kickstart your digital journey;
- A platform-based strategy for Quality 4.0;
- How Quality 4.0 supports FDA regulations; and
- Examples of successful digital Quality 4.0 efforts.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Daniela Jansen, Director, Solution Marketing, Dassault Systèmes BIOVIA
Recorded on: May 22, 2018
Description: Pharmacovigilance expert Angela Pitwood looks at compliance challenges for gene therapies and other novel treatments in personalized medicine. She discusses:
- Cutting-edge therapies that offer hope for conditions for which there are limited or no therapeutic options now;
- Development of advanced therapies; and
- FDA safety reporting requirements, both now and in the future.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Angela Pitwood, Vice President of Pharmacovigilance, Vigilare
Recorded on: May 16, 2018
Description: Attorney Roseann Termini addresses implications of the opioid crisis for drugmakers, healthcare providers and other regulated firms. She discusses:
- False Claims Act crackdowns on GMP violations and opioid overprescribing;
- Impact of the Senate probe of donations by U.S. opioid manufacturers;
- Lawsuits at state, local and tribal levels;
- Opioid deterrents; and
- New regulations, warnings, dosage limits from the Gottlieb task force.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Roseann Termini, Food and Drug Lawyer