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.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
- Determining whether a claimant (including an individual whose claim is unresolved) is entitled to Medicare;
- Submitting claimant information in the manner, form and frequency required by the FDA; and
- Penalties for failing to comply.
Presentation: Download the presentation
Speakers: David A. Charapp, Partner, Duane Morris LLP and Erin M. Duffy, Associate, Duane Morris LLP
- Building a technology knowledge base;
- Requiring CROs and CMOs to supply searchable PDF reports compliant with FDA specifications; and
- Using a process and checklists to verify that submission is complete and accurate.
Presentation: Download the presentation
Speaker: Antoinette Azevedo, Principal, e-SubmissionsSolutions.com
- Establishment of schedules for frequency;
- Establishment of defined procedures and methods to be used;
- Documentation of results; and
- Evaluation of deviations on equipment or product.
Presentation: Download the presentation
Speaker: Kenneth Christie, COO, Consulting Services at VTS Consultants Inc.
- Quality policy and quality objectives;
- Proper organization and adequate resources; and
- A management representative to oversee the QMS.
Presentation: Download the presentation
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
- Devising and maintaining a system of internal accounting controls sufficient to provide reasonable assurances that transactions are properly authorized and all amounts are recorded accurately;
- Understanding that the recordkeeping requirements cover all payments, not just those that would be “material” under other accounting requirements; and
- How a company can be in violation of the FCPA’s recordkeeping requirements even if it did not intend to break the law or to keep inaccurate books and records.
Presentation: Download the presentation
Speakers: Keith Korenchuk, Partner, Arnold & Porter, LLP and Samuel Witten, Counsel, Arnold & Porter, LLP
- Consider software for creating/routing/uploading disclosure records;
- Verify new informed consent letters for applicable clinical trials; and
- Adjust compliance strategies for international trials for which the researcher is the sponsor/responsible party.
Presentation: Download the presentation
Speaker: Barbara Godlew, RN, BA, President, The FAIRE Company, LLC
- Number of consignees notified of the recall, and date and method of notification;
- Number of consignees responding to the recall communication and quantity of products on hand at the time it was received;
- Number of consignees that did not respond; and
- Number of products returned or corrected by each consignee contacted and the quantity of products accounted for.
Presentation: Download the presentation
Speaker: James M. Wood, Attorney, Reed Smith
- The ins and outs of when to respond;
- When not to respond; and
- What evidence is most effective with the FDA.
Presentation: Download the presentation
Speaker: Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm
- Retrospective Case-Control;
- Retrospective Cohort;
- Crossover; and
- Randomized Control Trials.
Presentation: Download the presentation
Speaker: Dr. Debbie Wilkerson, Clinical Research Director, Medtronic Spinal
- Roles and responsibilities for personnel involved in inspections;
- How to greet inspectors and assemble the war room team; and
- When to call on outside experts for help.
Presentation: Download the presentation
Speaker: Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm