The Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs, feature top consultants, expert speakers and FDA officials.

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.

Many of our webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.

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Webinar Training Pass

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

Recorded on: Dec. 17, 2015

Description: Operations management specialist Dan O'Leary explains new regulatory requirements for laboratory-developed tests. He discusses:

  • The new requirements for adverse event reports that apply to LDTs;
  • The role of registration and listing, and the current fees;
  • The requirements for premarket review, the timing, and fee issues; and
  • LDTs that FDA won't regulate.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O'Leary, President, Ombu Enterprises, LLC

Recorded on: Dec. 16, 2015

Description: Food industry attorney Kathleen Hardee discusses safety regulations for food importers. She covers:

  • The two chief purposes of Accredited Third-Party Certification;
  • How the size of your business affects your compliance deadlines; and
  • The timeline for complying with the rule.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Kathleen A. Hardee, Co-Chair, Food & Ag Group, Polsinelli

Recorded on: Dec. 16, 2015

Description: Food industry attorney Kathleen Hardee explains new FDA rules on preventive controls for human and animal foods. She covers:

  • The FDA's "Seven Pillars" and the schedule for their implementation;
  • What your food safety plan must include; and
  • Who is a preventative controls qualified individual.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Kathleen A. Hardee, Co-Chair, Food & Ag Group, Polsinelli

Recorded on: Dec. 15, 2015

Description: Noted European law specialist Elisabethann Wright discusses developments in the EU's pharmacovigilance system. She covers:

  • The difference between getting marketing authorization and renewing it;
  • The new rules on post-authorization efficacy studies;
  • The powers of the Pharmacovigilance Risk Assessment Committee and their relationship with the Committee on Human Medicinal Products; and
  • The significance of the "Black Triangle."

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Elisabethann Wright, BL, Partner in Brussels, Belgium office, Hogan Lovells International