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: Feb. 24, 2016
Description: Pregnancy exposure specialist Cathy Sigler talks about ways to collect data on pregnancy with the focus on birth outcomes following in utero exposure to medicinal products. She discusses:
- The need for such data;
- Regulations and guidance; and
- Key outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Cathy Sigler, Senior Epidemiologist, United Biosource Corporation
Recorded on: Feb. 16, 2016
Description: Social media experts John McDaniel and Phil Baumann discuss how social media can be mined for information about adverse events. Topics include:
- The components and detail of structuring data into meaningful elements;
- The different approaches between monitoring HCP and consumer conversations;
- Technological considerations; and
- Best practices for monitoring and interacting on social media platforms.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: John McDaniel, Senior Director, and Phil Baumann, Social Media Strategist, C3i Healthcare Connections
Recorded on: Feb. 9, 2016
Description: Attorneys and medical device regulatory specialists Yarmela Pavlovic, Kelliann Payne and Lina Kontos explain the de novo procedure and tell you what you must do to ensure that your request includes all the data elements and supporting research the FDA requires. They discuss:
- FDA's evolving view of substantial equivalence and de novo reclassification;
- Making effective risk/benefit arguments that will pass FDA muster; and
- What happens after an initial de novo clearance, both for subsequent modifications and for competitive products in the same classification.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Yarmela Pavlovic, Partner, Kelliann Payne, Counsel, and Lina Kontos, Counsel, Hogan Lovells US, LLP
Recorded on: Jan. 29, 2016
Description: Regulatory and pharmaceutical counselor Darshan Kulkarni offers guidance on how to respond to enforcement activities of the FDA Office of Prescription Drug Promotion. He discusses:
- Recent trends in OPDP enforcement;
- Whether you should always respond to an enforcement action;
- The time frame for and goal of your response;
- What should be included in the response and what should be left out; and
- How to determine when do you need outside help.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Darshan Kulkarni, FDA Regulatory & Compliance Attorney, Kulkarni Law Firm
Recorded on: Jan. 27, 2016
Description: Supplier management expert Steven Sharf outlines the critical components of an effective supplier quality agreement. He also discusses:
- The importance of clearly defined roles in the complaint handling/adverse event reporting process;
- The need for a responsibility matrix to clearly identify what entity is responsible for which quality function; and
- Whether you should allow suppliers to use subcontractors.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Sharf, Senior Consultant, Validant
Recorded on: Jan. 26, 2016
Description: Systems management specialist Dan O'Leary interprets FDA regulations on handling nonconforming products. He discusses:
- The difference between correction and corrective action, as well as the types of correction;
- How to document a decision to use a nonconforming product;
- The need for retesting and reevaluation after rework and its relationship to acceptance activities; and
- How to link the investigation of nonconforming product to corrective action.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O'Leary, President, Ombu Enterprises, LLC
Recorded on: Jan. 20, 2016
Description: Medication safety specialist Dr. Susan Proulx discusses new drug naming guidances from both the FDA and Health Canada and advises on how to improve your chances of approval from these regulators. She covers:
- How the new guidances will affect drug trademark development;
- Pros and cons of relying on computerized searching to identify similarity in proposed names; and
- Using simulation testing — how to conduct testing similar to what the FDA will eventually do on your chosen drug name.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dr. Susan Proulx, President, Med-ERRS
Recorded on: Jan. 19, 2016
Description: Management system audits specialist Tom Middleton presents practical techniques for improving audit preparation, execution and post-audit activities for both internal and supplier audits. He covers:
- Managing the audit cycle using Enterprise Quality Management Software;
- Identifying trends and metrics; and
- Closing out an audit.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tom Middleton, Solutions Architect, Sparta Systems
Recorded on: Jan. 14, 2016
Description: Informed consent expert Susan Brink discusses strategies for implementing an electronic informed consent system. Topics include:
- Broad v. dynamic consent;
- Integration with other systems; and
- The process of setting up an eConsent system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan G. Brink, Executive Vice President, e-consent Products and Services, Enforme Interactive, Inc.
Recorded on: Dec. 22, 2015
Description: Industry veteran Gaurav Walia discusses developments in Good Automated Manufacturing Practice (GAMP). Topics include:
- GAMP 5 classification;
- GAMP risk-based approach to software classification; and
- Trends in regulatory citations and consent decrees.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Gaurav Walia, Pharmaceutical Consultant