Overview: CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM.
The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA.
Why Should You Attend: The webinar is designed for mid-level Quality Engineers and Quality Engineers who design and manage the Quality system.
What you will learn:
* The CAPA definition
* the CAPA LIFE cycle
* Tools for each CAPA cycle
* CAPA requirements
* Tools for Preventive Action
* Common FDA CAPA findings and how to avoid them
Areas Covered In the Session:
* Off-label statute
* Label claims
* Allowable reprints
* Promotional compliance
* FDCA: The law
Who will benefit:
* Sales executives in Medical Device
* Regulatory Affairs personnel
* Executives
* Corporate counsel
* Quality personnel
* Directors
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA.
Why Should You Attend: The webinar is designed for mid-level Quality Engineers and Quality Engineers who design and manage the Quality system.
What you will learn:
* The CAPA definition
* the CAPA LIFE cycle
* Tools for each CAPA cycle
* CAPA requirements
* Tools for Preventive Action
* Common FDA CAPA findings and how to avoid them
Areas Covered In the Session:
* Off-label statute
* Label claims
* Allowable reprints
* Promotional compliance
* FDCA: The law
Who will benefit:
* Sales executives in Medical Device
* Regulatory Affairs personnel
* Executives
* Corporate counsel
* Quality personnel
* Directors
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
