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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Webinar Training Pass
Recorded on: Oct. 30, 2019
Description: Technology experts Jon Carter, Catie Roland and Mark Tomlinson share the differences between EDC and eSource and offer guidelines to help select solutions that suite clinical trial needs. They discuss:
- Pros and cons of EDC vs. eSource;
- The challenges of eSource adoption and pitfalls to anticipate and avoid;
- When should EDC and/or eSource be implemented; and
- Should EDC and eSource be combined in the same study.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jon Carter, Product Manager; Catie Roland, Program Manager; Mark Tomlinson, Senior Director of Technology Operations; Cmed Technology
Recorded on: Oct. 29, 2019
Description: Regulatory expert Alan Minsk shares best practices for adhering to the recent Instruction for Use (IFU) guidance and expected implications on new drug applications and biologics license applications. He discusses:
- How the current content and format for IFUs will need to be modified;
- Examples of sample labeling that cover all elements of an IFU—from dosage and usage to storage and disposal;
- Examples of the kind of recommendations the FDA makes in terms of design and layout; and
- Practical considerations on patient labeling.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Alan Minsk, partner, Arnall Golden Gregory LLP
Recorded on: Oct. 15, 2019
Description: Device expert Connie Hoy shares best practices for responding to nonconformities found during an audit inspection. She discusses:
- How to analyze the criticality of the audit findings;
- How to avoid complicating the corrective actions and inadvertently overburdening organizations;
- How to prioritize plans by identifying corrections and corrective actions;
- How to write a sufficient corrective action and preventive action (CAPA) procedure; and
- How to draft an appropriate response to the auditing agency.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Connie Hoy, Founder, Hoy & Associates Regulatory Consulting
Recorded on: Oct. 10, 2019
Description: Risk management expert Mark Levy shares best practices for having a solid process for compliance with current law and guidance in regard to medical product off-label use and marketing. He discusses:
- The current law and guidance on off-label promotion and how it affects quality, regulatory and compliance professionals;
- How to detect potential allegations of wrongdoing and how to deal with them;
- The nuances of the False Claims Act and how the First Amendment intersects with claims; and
- How to conduct an effective internal investigation when alleged unlawful off-label promotion is detected.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mark Levy, Litigator and Trial Attorney, Eckert Seamans
Recorded on: Oct. 9, 2019
Description: Quality systems expert Dan O’Leary shares insights to help find solutions to the five highest-risk areas that prompt 483s and warning letters. He discusses:
- The most commonly cited section in warning letters;
- The distribution of warning letters by source, region and part;
- The Forgotten Five — the bottom 5 of the top 10 — most cited observations;
- The issues cited in the warning letters; and
- How to address the issues before inspection.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: Oct. 9, 2019
Description: Technology expert Filip Matakovic shares best practices for making a paperless transition, including how updated guidelines and new technology have lowered the hurdles and streamlined the transition to going electronic. He discusses:
- System compliance and audit readiness;
- The costs and current methodologies of paper binder storage;
- The advantages of managing documents electronically; and
- eSignatures and Part 11 compliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Filip Matakovic, Vice President and General Manager, Site Services Group, MedPoint Digital
Recorded on: Oct. 8, 2019
Description: Regulatory experts Dirk Rodgers, Susanne Somerville and Joseph Lipari share best practices for staying up-to-date on the changing pharma regulatory landscape along with VRS solutions. They discuss:
- The evolving serialization mandates for Russia, China, India and Egypt;
- Blockchain and interoperability;
- The saleable returns mandate.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Dirk Rodgers, Regulatory Strategist, Founder of RxTrace.com; Susanne Somerville, Chief Executive Officer, Chronicled; Joseph Lipari, Director, Cloud Products, Systech
Recorded on: Oct. 4, 2019
Description: Experts Julie Larsen and Lenita Sims-Spears share best practices for keeping abreast of the changes, and potential impact, brought by VMSR and NEST. They discuss:
- The real-world impact new medical device reporting programs will have following the formal end to the ASR program;
- How the FDA is transitioning to the VMSR program;
- Which devices and device malfunctions are eligible, or not, for summary reporting in VSMR; and
- The critical components of FDA’s NEST initiative and how the FDA will monitor medical device performance through NEST.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Julie Larsen, Principal Consultant and Director of Inspection Readiness Services, BioTeknica, Inc.; Lenita Sims-Spears, Senior QARA Consultant, BioTeknica, Inc.
Recorded on: Oct. 2, 2019
Description: Clinical experts Irina Petrova and Anna Yanaeva share best practices for preparing to choose the right CRO for your organization, whether they be local or globally located. They discuss:
- How to select the right CRO — Does the CRO have global reach, local regulatory expertise, brand recognition, speed of decision-making, advanced technologies and competitive pricing;
- What pharma-CRO relationships are like — Why are most pharma firms unsatisfied with their experiences;
- How to choose a CRO based on therapeutic area expertise.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Irina Petrova, Director of Clinical Operations; Anna Yanaeva, Director of Business Development; OCT Clinical Trials
Recorded on: Sept. 27, 2019
Description: Regulatory experts Cynthia Schnedar and Liz Oestreich share best practices for exploring the new inspections landscape of the Mutual Recognition Agreement (MRA). They discuss:
- The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and what it has led to;
- How inspectors are using each other’s inspections to maintain a risk-based approach, to include potential benefits for U.S. drug safety;
- How the MRA may complicate regulatory and compliance operations — which inspections will the FDA continue to perform, and which will be assigned to EU member states; and
- What’s next for FDA capability assessments and the possibility of duplicating the MRA model in other regions, including the potential impact of ‘Brexit’ on the MRA.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Cynthia Schnedar Esq., Executive Vice President, Regulatory Compliance; Liz Oestreich Esq., Vice President, Regulator Compliance, Greenleaf Health Inc.