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: Device regulatory expert John Avellanet analyzes FDA 483s and warning letters issued in 2013 and points out how devicemakers can learn from others' mistakes when it comes to dealing with suppliers. He covers:

  • The most commonly cited violations;
  • Key documents to have ready for FDA investigators; and
  • Typical questions investigators ask about supplier qualification and management.

Presentation: Download the presentation

Speaker: John Avellanet, Principal Consultant, Cerulean Associates

Description: Noted food and drug legal expert Alan Minsk explains why it is important to have a strong quality agreement with suppliers and contractors. He discusses:

  • FDA enforcement trends;
  • Tips and tools for developing quality agreements; and
  • Who is ultimately responsible – manufacturer or supplier – for maintaining compliance with quality standards.

Presentation: Download the presentation

Speaker: Alan Minsk, Partner and Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP

Description: Medical device quality expert Jackie Torfin presents a new strategy for supplier qualification based on quantitative risk assessment. She covers:

  • Areas of competency the tool is designed to assess;
  • Various ways to implement the assessment tool; and
  • A real-life case study that demonstrates how the tool works.

Presentation: Download the presentation

Speaker: Jackie Torfin, Vice President of Quality, Heraeus Medical Components

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