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
Description: Quality and compliance expert Albert Ghignone, CEO of AAG Incorporated, demonstrates proven tactics for requesting, preparing for and conducting FDA Pre-Submission Program meetings. He will cover:
- How to prepare an effective pre-submission package to submit to the agency in advance;
- How to understand and prepare for the different types of pre-submission meetings, including insight on which type to request and how to support that request; and
- The most effective way to request, prepare for and conduct all varieties of pre-submission meetings.
Presentation: Download the presentation
Speaker: Albert Ghignone, CEO, AAG Incorporated
Description: CDRH's M. Isabel Tejero outlines the FDA's focus on controlling supplier quality, including:
- Common issues that appear in inspections;
- How suppliers should meet their client manufacturer's requirements; and
- Supplier assessment methods devicemakers can use.
Presentation: Download the presentation
Speaker: M. Isabel Tejero, Acting Lead, Quality Systems Working Group, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA
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