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.
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Webinar Training Pass
Recorded on: July 11, 2018
Description: Regulatory compliance expert Connie Hoy explains the Medical Device Single Audit Process. She discusses:
- Using the companion document as a preparation guide;
- Ensuring your quality system covers specific country requirements;
- Questions auditors are likely to ask; and
- How the process differs from FDA inspections and ISO audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Connie Hoy, President, Hoy & Associates Regulatory Consulting
Recorded on: June 21, 2018
Description: Clinical research compliance experts Jennifer Mallory and Carrie Hanger provide an overview of changes in the Common Rule set to take effect in January 2019. They discuss:
- Broad consent for secondary research;
- Limited and continuing IRB review;
- Exemptions;
- Federalwide assurances; and
- Cooperative research.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jennifer Mallory and Carrie Hanger, partners, Nelson Mullins Riley & Scarborough
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
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
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