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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
Recorded on: Feb. 15, 2023
Description: Half of the effectiveness of your CAPA depends on how well you write it. In this advanced compliance writing webinar, you learn:
- The difference between root cause analysis and failure investigation;
- How to plan for a systematic investigation of discrepancies to prevent recurrence;
- The blueprint for expert root cause analysis; and
- Failure investigation pitfalls with FDA warning letter review.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Judith Meritz, Life Sciences Regulatory Consultant, Meritz & Muenz LLP
Recorded on: Feb. 9, 2023
Description: Industry thought leader Kara Quinn dives deep into the concept of quality culture and the role data integrity plays in it. She explains:
- How the FDA measures quality culture through the lens of warning letters citing data integrity failures;
- FDA inspection trends related to quality and data integrity;
- How to comply with the FDA’s guidance on data integrity by taking a back-to-basics approach; and
- How to differentially apply FDA’s guidance to electronic vs. paper-based systems.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kara Stockett Quinn, Consultant
Recorded on: Feb. 8, 2023
Description: Dave Petrich, vice president of quality and regulatory at the Landrich Group, shares everything you must know to improve your design and process validation to ensure the safety, quality and integrity of your medical devices, including:
- Best practices in design and process validation;
- The regulatory basis for design and process validation; and
- Trends in 483s and warning letters that impact both design and process validation.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dave Petrich, Vice President of Quality and Regulatory, Landrich Group
Recorded on: Feb. 1, 2023
Description: Due to the ongoing Quality Management Systems (QMS) regulatory changes, the healthcare or Medtech industry is well aware and confused about the changing requirements and standards. Sundeep Agarwal discusses:
- Planning and strategy for EQMS implementation;
- The basic components of today’s QMS enabling remote audits and remote work culture;
- Why EQMS is vital today; and
- How to Choose the right EQMS.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sundeep Agarwal, Medical Device Expert & Consultant
Recorded on: Jan. 26, 2023
Description: Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice — Kellie Combs and Sarah Blankstein — share what you must know about qualifying criteria, what data or other information the FDA may expect, when to initiate discussions with the agency and best practices for securing the benefits, explaining:
- The meaning of key terms, including “serious condition,” “available therapies” and “unmet medical need”;
- Eligibility criteria, including data-generation requirements;
- Timing and content considerations for designation requests and applications for expedited approval programs; and
- How to qualify for multiple programs.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kellie Combs, Partner, Ropes & Gray; and Sarah Blankstein, Counsel, Ropes & Gray
Recorded on: Jan. 24, 2023
Description: Ellen Weiss — PCM Trials’ vice president, in-home solutions, decentralized clinical trials — explains how deploying a team of properly trained mobile research nurses can transform your remote trials, making them more efficient and more diverse, while improving participant retention. You’ll understand:
- Which qualifications mobile research nurses must have for the biggest trial efficiencies and benefits;
- Which specific activities they are authorized to carry out in the patient’s home;
- The specialized training mobile research nurses must have; and
- How to ensure adherence to good clinical practice (GCP) and constraint-induced therapy (CIT) when using a mobile nursing workforce.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ellen Weiss, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials
Recorded on: Jan. 19, 2023
Description: Susan Schniepp moderates a discussion with four of the most respected professionals in the field that takes a deep dive into the most important issues faced in developing and effectively utilizing world-class audits. They discuss:
- How to use a risk-based approach to audits;
- The importance of quality culture and regulatory requirements identifying quality culture;
- Steps to take when a quality issue is identified through the audit process; and
- The best practices for documenting and tracking resolutions to identified issues.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates; Seyed Khorashahi, Executive Vice President of Medical Device and CTO, Regulatory Compliance Associates; Steve Lynn, Executive Vice President of Pharmaceuticals; Michael de la Torre, CEO, Redica Systems
Recorded on: Jan. 18, 2023
Description: Mickey Landkof, general manager and global vice president of sales for Dot Compliance, shares how to choose the right QMS software system for your company and use industry best practices to get it up and running in 30 days. He clarifies:
- Why it takes so long for traditional QMS solutions to go live;
- The steps required for a 30-day QMS implementation;
- How to save time, money and resources, and decrease time to market by doing away with fully customized QMS solutions; and
- How to build a future-ready strategy.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mickey Landkof, General Manager and Global Vice President of Sales, Dot Compliance
Recorded on: Jan. 17, 2023
Description: Shelly Garg, president and founder of the FDA regulatory compliance law firm Garg Law, explains the device marketing requirements and the various benefits, challenges and drawbacks associated with different regulatory pathways. She shares:
- How a device is classified by the FDA;
- How to determine whether your company’s product is a medical device and how the FDA intends to classify and regulate it;
- Features, benefits, challenges and drawbacks of device marketing pathways, including premarket notification (510(k)), Premarket Approval (PMA), De Novo, Humanitarian Device Exemption (HDE) and Custom Device Exemption (CDE); and
- Best practices and what the FDA is looking for in each pathway approach.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Shelly Garg, President and Founder, Garg Law
Recorded on: Dec. 15, 2022
Description: Donna Dorozinsky shares a strategy for identifying key parts that represent your study’s unique inspection risks, what you can do now to become more inspection prepared and the key processes you can put into place at study start-up so you’re continually inspection-prepared. You’ll learn:
- How to identify key study activities where inspection risk may exist;
- An approach that allows you to understand your study’s story even if you were not a participant in the management of the study;
- How to identify key processes to put in place at study start-up to ensure that inspection preparation is integral to routine business; and
- Ideas for better inspection preparation.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Donna Dorozinsky, President and CEO, Just in Time GCP