The Webinar Training Pass

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar 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.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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.

Select 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: 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.

Description: Certified quality auditor Robert Schiff describes his experiences as a veteran of numerous GMP inspections and points out the 10 most commonly noted violations. Schiff discusses:
  • CAPA failures;
  • Lack of out-of-specification, nonconformance and deviation investigations;
  • Inadequate complaint handling; and
  • Failure to follow established SOPs.

Presentation: Download presentation

Speaker: Robert Schiff Ph.D., CEO, Schiff & Company

Description: Validation expert Rich Yeaton reveals the front-line cleaning validation techniques needed to stay FDA compliant. Yeaton discusses:
  • Developing and implementing a Cleaning Validation Master Plan;
  • The three key parts of a cleaning validation program;
  • Cleaning acceptance criteria; and
  • Appropriate analytical methods.

Presentation: Download presentation

Speaker: Rich Yeaton, President, East Coast Validation Services LLC

Description: Dietary supplements expert Ivan Wasserman discusses how FDA adverse event reporting rules apply to OTCs and supplements just as they do to prescription drugs and explains all facets of the reporting process, including:
  • How to identify adverse events;
  • Collecting data on the event;
  • Documenting the event; and
  • Reporting procedures.

Presentation: Download presentation

Speaker: Ivan Wasserman, Partner, Manatt Phelps & Phillips LLP
 

Description: Clinical trial specialist Charles Pierce educates research facilities and investigators on how to identify and report on adverse events that occur in their trials and make sure they comply with FDA’s and other authorities’ requirements. Pierce covers:
  • Definitions and types of adverse events;
  • Investigators’ responsibilities;
  • Monitoring and reporting adverse events and managing risk; and
  • Common mistakes in reporting.

Presentation: Download presentation

Handout Adverse Event Study Medication Relationship

Speaker: Charles H. Pierce MD, PhD, FCP, CPI, Pierce One Consulting