The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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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.
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Webinar Training Pass
Recorded on: May 27, 2015
Description: Intellectual property law attorney Jonathan Losk discusses new court rulings and significant changes in intellectual property law that could impact you and your business. Topics include:
- How to assess the adequacy of your product's patent protections;
- How to address unsolicited disclosures and manage joint inventions;
- How to best respond to theft of intellectual property; and
- The newest interpretations of infringement by inducement.
Presentation: Download the presentation
Speaker: Jonathan Losk, Partner, Knobbe Martens
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: May 21, 2015
Description: Consultant Jerry Dalfors presents various approaches for validating, monitoring and controlling sterilization processes. Topics include:
- How to use survivor curves, to determine D-values and Z-values;
- Calculation of process lethality;
- Which biological indicators to use and how to make the selection; and
- What laboratory studies are best for supporting sterilizer studies.
Presentation: Download the presentation
Speaker: Jerry Dalfors, Principal, JD Technologies
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: May 20, 2015
Description: Former CDRH official and UDI rule co-author Jay Crowley explains requirements and presents best practices for implementing new UDI programs. Topics include:
- The difference between UDI and track and trace;
- The timetable for implementation for Class I, Class II and Class III devices;
- Which devices must comply with the rule and which are exempt; and
- What information must be included on product labels.
Presentation: Download the presentation
Speaker: Jay Crowley, Vice President, UDI Practice, USDM Life Sciences
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: May 19, 2015
Description: Consultants Marie McDonald and Glen Potvin present a proven approach to uncover and address data integrity issues within companies and their partner networks. Topics include:
- How to characterize the scale and scope of issues;
- How to design and deploy a remediation strategy; and
- Best practices for tailoring solutions to the problems identified.
Presentation: Download the presentation
Speakers: Marie McDonald, Vice President, and Glen Potvin, Senior Director, Quintiles Consulting
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: May 7, 2015
Description: Process and organization expert Ron Snee presents a holistic approach to QbD with a focus on enabling effective process development, quality improvement and compliant operations. Topics include:
- Why the FDA is focusing on QbD;
- How QbD benefits both sponsors and their CMOs;
- Best practices for understanding and reducing risk; and
- When and how to revise your SOPs, training programs and general culture to effectively deploy QbD in an organization.
Presentation: Download the presentation
Speaker: Ron Snee, Founder and President, Snee Associates
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 30, 2015
Description: Process expert Jerry Dalfors explains the intricacies of developing and improving batch production records and device history records. Topics include:
- Proven strategies for reducing employee errors;
- Best practices for writing BPRs/DHRs to assure they generate objective evidence;
- Developing Incident Tracking Systems that assure all incidents are recorded as they occur and noted properly within the lot packet; and
- Understanding the nine instructions given to FDA investigators regarding review of batch records.
Presentation: Download the presentation
Speaker: Jerry Dalfors, Principal, JD Technologies
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 29, 2015
Description: Dr. Rita Redberg and Dry. Sanket Dhruva discuss the problems presented by low participation of women as subject in clinical trials and offer strategies for reducing this gender disparity. Dr. Redberg discusses:
- The current status of women’s representation in clinical trials and sex-specific reporting of clinical trial data;
- Reasons for low participation of women in clinical trials; and
- Requiring gender-specific quality indicators in clinical trials.
Presentation: Download the presentation
Speakers: Rita F. Redberg MD MSc, Professor of Medicine and Director of Women’s Cardiovascular Services at UC-San Francisco and Chief Editor of JAMA Internal Medicine; Sanket Dhruva MD, Cardiology Fellow, UC-Davis Medical Center
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 28, 2015
Description: Device expert and inventor James (Rusty) Lusk demonstrates how to stress-test a CAPA program to identify and address any weaknesses. He covers:
- Understanding the most effective part of a CAPA system where the thought process and the documentation process overlap to truly produce results;
- How to identify and solve the 5 common CAPA problems;
- Using effective flow charts to determine when to trigger a CAPA; and
- Writing CAPA reports — with proper supporting documentation — that FDA investigators will accept.
Presentation: Download the presentation
Speaker: James (Rusty) Lusk, Principal, Quality Systems International
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 23, 2015
Description: Clinical trial regulatory expert Darshan Kulkarni provides an overview of the FDA guidance on risk-based monitoring of clinical trials. He covers:
- Developing a centralized risk-based approach;
- Factors to consider in developing a monitoring plan; and
- Communicating monitoring results.
Presentation: Download the presentation
Speaker: Darshan Kulkarni, Kulkarni Law Firm, PC
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: April 16, 2015
Description: Aseptic systems expert Herman Bozenhardt explores modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years and enhance compliance. He discusses:
- How unidirectional flows and architectural layout can boost productivity;
- How to use automation and portable systems to deliver product faster; and
- The top operational upgrades in material handling that every manufacturing professional should know.
Presentation: Download the presentation
Speaker: Herman Bozenhardt, Bozenhardt Consulting Services, LLC
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.