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: Industry analyst Jason Spiegler uses case studies to demonstrate how a preventive approach to CAPA can save time and money. Topics include:

  • Benefits of a preventive CAPA program;
  • The smartest investments to make; and
  • How to leverage CAPA beyond compliance.

Presentation: Download the presentation

Speaker: Jason Spiegler, Director, Strategic Market Development, Camstar Systems; Chair, ASQ Charlotte, NC Section

Description: Quality assurance specialist Ken Miles offers insider tips on inspections gleaned from his 28 years as an FDA medical device investigator. He covers:

  • What investigators are thinking when they walk into your plant;
  • How to anticipate and deal with potential red flags; and
  • How other companies' bad CAPA compliance programs can be a learning tool.

Presentation: Download the presentation

Speaker: Ken Miles, Principal, Alpha Quality Assurance

Description: CAPA guru Dan O'Leary explains what data analysis techniques devicemakers need to survive FDA scrutiny of their CAPA systems. Topics include:

  • Creating procedures to drive effective CAPA compliance;
  • Developing strong procedures for quality reports and records; and
  • Using FDA-required statistical methodologies.

Presentation: Download the presentation

Handout: Download the handout

Speaker: Dan O'Leary, President, Ombu Enterprises

Description: Compliance expert Greg Meyer discusses how to behave ethically and scientifically when analyzing a limited number of data points. Topics include:

  • Core principles in CAPA, statistical analysis and statistical process control that come into play when conducting investigations; and
  • Historical and practical precedents for determining when statistical tools are appropriate when making quality decisions.

Presentation: Download the presentation

Speaker: Greg Meyer RAC, CQA, President and Principal Consultant and Trainer at Compliance Media Inc.

 

Description: Legal authority and 505(b)(2) expert Kurt Karst explains how and when to use this alternative drug approval process to get new products to market faster. Topics include:

  • Patent and non-patent marketing exclusivity;
  • Recent legal activity; and
  • FDA policies and interpretations.

Presentation: Download the presentation

Speaker: Kurt Karst, Director, Hyman, Phelps & McNamara

 

Description: FDA regulatory expert Seth Mailhot discusses the implications of the HIPAA and HITECH acts for manufacturers of devices that store patient information. Topics include:

  • Who and what is regulated under HIPAA;
  • Business associate liability; and
  • Research and FDA reporting exemptions.

Presentation: Download the presentation

Speaker: Seth Mailhot, Partner and Lead, FDA Regulatory Practice, Michael Best and Friedrich LLP

 

Description: Jay Crowley, who led the FDA team that wrote the UDI rule, talks about the most important questions and issues that remain to be resolved as the September 2014 implementation date looms. Among the challenges he discusses are:

  • Switching to a standardized date format;
  • How to treat stand-alone software;
  • The single-use device exemption; and
  • Definitions of "shipping container," "reprocessing" and "labeler."

Presentation: Download the presentation

Speaker: Jay Crowley, Vice President of the UDI practice at USDM Life Sciences

 

Description: Former FDA official David Lim presents a plan for inspection preparation, focusing on the top 20 problems that continually show up in 483s and warning letters and how to avoid them. Topics include:

  • Resources FDA investigators use to prepare for inspections;
  • Factors that determine the depth of an inspection; and
  • Tips for communicating with investigators before, during and after the inspection.

Presentation: Download the presentation

Speaker: Dr. David Lim, President and CEO, RegulatoryDoctor.com

 

Description: Regulatory experts Timothy Ayers and Michelle Axelrod examine the FDA's new enforcement focus on television ads, trade show communications and Twitter activities, offering advice on how to respond to agency citations and develop a compliant promotions plan. Topics include:

  • Common violations cited in 2013 Warning Letters;
  • FDA enforcement of digital communications violations; and
  • How to set standards and safeguards to ensure claims are legally defensible.

Presentation: Download the presentation

Speakers: Timothy Ayers, Principal, Life Sciences Compliance, Commercialization and Regulatory Counseling Department, Porzio, Bromberg and Newman; Michelle Axelrod, Principal, Porzio, Bromberg and Newman.

 

Description: In a special question-and-answer session, Steve Silverman, Director of CDRH's Office of Compliance discusses the recent reorganization of the office and what it means for devicemakers. Led by FDA veteran Steven Niedelman, the webinar addresses the responsibilities of the:

  • Program Management Office;
  • Division of Manufacturing and Quality;
  • Division of Premarket and Labeling Compliance;
  • Division of International Compliance Operations;
  • Division of Bioresearch Monitoring; and
  • Division of Analysis and Program Operations.

Presentation: Download the presentation

Speakers: Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences Practice Team, King & Spalding, and Steve Silverman, Director, Office of Compliance, CDRH.