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

Description: Global legal experts Cristiana Spontoni and Maureen Bennett examine medical device approval regulations from both the U.S. and EU perspectives and discuss how they differ. Topics include:
  • Device classification;
  • Clinical investigation;
  • Basic regulatory references; and
  • Definitions and interpretation of differences.

Presentation: Download presentation

Speakers: Cristiana Spontoni, European Partner, Squire, Sanders & Dempsey LLP and Maureen Bennett, Partner, Squire, Sanders & Dempsey LLP

Description: Global compliance expert Annalisa Pizzarello discusses best practices in how to write SOPs and train staff to follow them. Topics include:
  • Developing a documentation strategy;
  • Identifying roles and responsibilities; and
  • Reviewing and revising SOPs throughout their lifecycle.

Presentation: Download presentation

Speaker: Annalisa Pizzarello, Head of Global Compliance, Amgen

Description: Validation expert Melissa Smith imparts the basics of analytical method validation and how to maintain compliance with FDA rules. Smith covers:
  • Elements and types of method validation;
  • When and how to validate methods;
  • Setting specification criteria; and
  • International Conference on Harmonization quality guidelines.

Presentation: Download presentation

Speaker: Melissa Smith, Co-chair, PDA Task Force for Method Development and Qualification

Description: Former FDA insider David Rosen explains the FDA clinical trial inspections process and offers insight into preparing for GCP audits. Topics include:
  • Common findings of GCP inspections;
  • Roles of sponsors, IRBs and individual investigators in FDA-regulated research; and
  • Types of sanctions and other consequences of noncompliance.

Presentation: Download presentation

Speaker: David Rosen, Partner, Foley & Lardner

Description: Compliance expert Gordon Richman clarifies the FDA’s Part 11 focus on electronic systems as part of GMP inspections and offers advice for preparing systems to pass muster. Richman discusses:
  • Background and development of the Part 11 regulations;
  • How the FDA’s 2010 Part 11 “Tag-Along” Inspections initiative was used to evaluate the industry’s understanding of and compliance with the regulations; and
  • Common industry mistakes and misconceptions.

Presentation: Download presentation

Speaker: Gordon Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest

Description: Jack Garvey, founder of Compliance Architects, interprets the FDA guidance “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products,” discusses the agency’s intent in creating the guidance and identifies potential problem points, including:
  • Documenting substantiation for reduced activities to carry out an emergency plan;
  • Securing alternative resources;
  • FDA use of “enforcement discretion;” and
  • Setting activation criteria.

Presentation: Download presentation

Speaker: John C. “Jack” Garvey, Founder, Compliance Architects

Description: Biotech consultant Chitra Edwin presents the 10 key elements FDA inspectors look for in GLP audits and explains what to do to pass inspection on all counts. Areas covered include:
  • Facilities and equipment;
  • Organizational structure;
  • Protocols and procedures; and
  • Data and document management.

Presentation: Download presentation

Speaker: Chitra Edwin Ph.D RAC, Principal, Biotechnology Consulting Solutions

Description: Quality and organization expert Dan O’Leary provides advice on how to craft supplier quality agreements that meet regulators’ requirements. O’Leary discusses:
  • Quality System Regulation requirements for purchasing;
  • Supplier qualification;
  • Scope and primary elements of a supplier agreement; and
  • Working with third-party suppliers.

Presentation: Download presentation

Handout: Download handout

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

Description: Is the FDA about to name you their fraud police? A proposed new rule will require sponsors to report data falsifications … without any proof … without a possible motive … and even if there’s only a suspicion of fraud. The FDA sent shockwaves through the industry on Feb. 19 when it announced a proposed rule called “Reporting Information Regarding Falsification of Data.” The rule will require sponsors to report any information that indicates that a person has, or may have, engaged in the falsification of data involving clinical investigations, nonclinical laboratory studies and clinical studies in animals. What exactly is going on here? Is the FDA trying to turn sponsors into detective, judge and jury? Learn more about this controversial proposal in this presentation.

Presentation: Download presentation

Speakers: David Clissold, Director, Hyman, Phelps & McNamara and Nisha Shah, Associate, Hyman, Phelps & McNamara

Description: Regulatory specialist Gina Ross shows how to create a content development and organization strategy for developing electronic Common Technical Documents and how to develop authoring SOPs that ensure global compliance. Ross discusses:
  • How to train staff to write eCTDs;
  • Managing the document throughout its lifecycle; and
  • The decision-making process for most effective integration of regulatory strategies and eCTD lifecycle management

Presentation: Download presentation

Speaker: Gina Ross, Manager of the Regulatory Publishing Department, Beckloff Associates Inc.