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
Recorded on: Dec. 10, 2019
Description: A panel of experts discusses the pharmaceutical regulatory climate in the coming year. They cover:
- The impact of the new FDA commissioner;
- Drug pricing;
- Drug importation; and
- Generics competition.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Wayne Pines, President of Healthcare, APCO Worldwide; John Kamp, Washington Counsel, Coalition for Healthcare Communication; Kevin Madagan, Partner, Reed Smith; Tish Pahl, Principal, OFW Law
Recorded on: Dec. 9, 2019
Description: Intellectual property experts Chad Landmon and Neema Kumar explore FDA and congressional initiatives to promote generic drug competition. They discuss:
- Implementation of the FDA’s Drug Competition Action Plan;
- Pathways to expedited approval of generic drug applications; and
- How to obtain 180-day exclusivity.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Chad Landmon, Chair, FDA and IP practice groups, Axinn, Veltrop & Harkrider LLP; Neema Kumar, Senior IP Counsel, Hikma Pharmaceuticals USA
Recorded on: Dec. 2, 2019
Description: Regulatory specialist William Garvin provides an update on the implementation processes of the DSCSA. He discusses:
- Handling of suspect and illegitimate products;
- Confirming authorized trading partners;
- Product serialization and exchange of transaction information, transaction history and transaction statement; and
- Recent FDA enforcement actions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: William Garvin, Attorney, Buchanan Ingersoll & Rooney PC
Recorded on: Nov. 25, 2019
Description: Regulatory experts John Fuson and Chalana Damron share current FDA enforcement trends to prepare you for your next inspection. They discuss:
- 2019 FDA enforcement activity—483s and warning letters—versus prior years;
- The most prevalent targets of FDA inspections;
- GMP violations most often cited in 483s and in warning letters; and
- How to manage inspections to minimize the risk of escalation.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: John Fuson, Partner in the Health Care, Product Risk Management (PRM) and White Collar and Regulatory Enforcement groups; Chalana Damron, Counsel in the Mass Tort, Product and Consumer Litigation group; Crowell & Moring, LLP
Recorded on: Nov. 21, 2019
Description: Device regulation expert Dan O’Leary shares the challenges of complying with unique device identification (UDI) rules and major variances from FDA regulations in preparation to meet the May 2020 deadline. He discusses:
- The EU’s UDI system;
- Requirements for devices and packages;
- The role and uses of Basic UDI-DI; and
- EU-MR Article 120 transition requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: Nov. 19, 2019
Description: Quality expert Leslie Sam shares best practices for how to leverage ICH E8(R1) revised guidelines’ quality-by-design approaches, expanded study designs and data source considerations. She discusses:
- The scope and general principles of the ICH E8(R1) guideline;
- The impact to current research practices that may be outlined in SOPs, procedures, processes and documentation;
- The framework and approaches for identifying critical to quality factors; and
- The best way to identify clinical development areas that may be impacted by the adoption of the ICH E8(R1) guideline as well as approaches for compliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Leslie Sam, Principal Consultant, Wool Consulting Group
Recorded on: Nov. 14, 2019
Description: Clinical experts Maryan Zirkle, Elizabeth Shenkman and Adrian Hernandez share best practices on how to transform the culture of clinical research from one directed by researchers to one driven by the needs of patients and those who care for them. They discuss:
- How to transform trials with information on the patient-centered ecosystem;
- How to obtain information on the health systems, health plans and other stakeholders involved in the infrastructure;
- How PCORnet® is used as a resource in conducting various types of research; and
- How to optimize infrastructure with respect to specific conditions and communities.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Maryan Zirkle, PCORI Associate Director, PCORnet®; Elizabeth Shenkman, Professor and Chair, Department of Health Outcomes and Biomedical Informatics, University of Florida; Adrian Hernandez, Vice Dean for Clinical Research, Duke University School of Medicine
Recorded on: Nov. 12, 2019
Description: Clinical research experts Kerry Dyson and Kris O’Brien share real-world case studies that show how patient engagement leads to successful data capture and better outcomes. They discuss:
- How to approach project planning for the best outcomes in patient participation;
- Case studies of successful patient engagement during actual trials;
- Viewing patients as research partners and the steps needed to keep them involved; and
- Sustaining engagement and motivation throughout a trial.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kerry Dyson, Global Head of Clinical Research; Kris O’Brien, Vice President of Client Strategy and Development; CROMSOURCE
Recorded on: Nov. 5, 2019
Description: Design control statistical expert Steven Walfish shares best practices for understanding the requirements for statistical techniques and how they impact the design control process and sample size issues. He discusses:
- How to appreciate the nuanced interpretations of 21 CFR 820.250;
- How to recognize the differences between confidence and reliability in the sample size;
- How to understand the importance of how data is collected and how to justify the sample size;
- How to incorporate statistical assumptions as part of all sampling plans; and
- How to grasp how variance in the population impacts the sample size necessary to establish objective evidence.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Walfish, president, Statistical Outsourcing Services
Recorded on: Oct. 31, 2019
Description: Human error reduction expert Ginette Collazo shares best practices for minimizing human error and regulatory citations in manufacturing. She discusses:
- How to prepare an outline and develop world-class SOPs;
- The interrelationship between SOPS, quality and regulatory compliance;
- Why human error is a root cause for lack of quality and how to minimize it; and
- How to create and maintain a procedure that minimizes human error.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ginette Collazo, chief executive officer, Human Error Solutions