Webinar Recording - FDA CAPA Inspections: A Primer for Successful Execution

INSTRUCTOR: William McQuillan, Global Manager Change Document and Record Management and CAPA Subject Matter Expert, Cordis, a Johnson & Johnson Company

➢This recording is now part of a CONTENT Package. Read more...

➢Invite as many co-workers as possible for this training. Quality content training for one low price (only ONE login allowed - must be in one location).

➢PowerPoint Presentation (PDF)

➢Webinar recording

➢Frequently Asked Questions & Answers Subject Matter Document

➢Free Membership in enKap's FDA Compliance learning community - simply fill out a profile

Webinar Content

➢Introduction: 21 CFR 820 Subpart J Regulation

➢Preparing for the FDA Inspection: File preparation, “Staging room “setup,facilitation and staffing

➢Managing an FDA CAPA Inspection: CAPA owner preparation, Information flow from the staging room to the inspection area, Recording information and context communication related to questions being asked, Time management, Areas the FDA will target in your CAPA program/files

➢FDA Inspection Areas of Focus. Examples include: CAPA initiation, CAPA timelines, CAPA effectiveness

➢Appropriate Responses During the Inspection: Examples will be offered as to how to appropriately respond to the investigator’s questions.

➢FDA Inspection Findings –Latest Industry Trends and Warning Letters: What the latest trends mean to your organization, How to prepare communication to site leadership to incorporate changes related to the trends

➢Benefits of Compliance to CFR 820 Subpart J

➢Information and Resources: FDA website, CAPA resources

QUESTIONS AND ANSWERS

There will be a 15-minute question and answer period for attendees to submit questions. If we are unable to answer your question due to time constraints, our instructor Will McQuillan will provide an email response after the webinar concludes.

WHAT ATTENDEES WILL LEARN IN THIS WEBINAR

In this webinar, you will review or learn the following:

➢Basic elements of CFR 820 Subpart J (CAPA)

➢How to prepare for an FDA inspection

➢Effective management of an FDA inspection

➢Areas the FDA will target during an inspection

➢Appropriate responses during the inspection

➢FDA inspection findings –latest industry trends and warning letters

➢Compliance with CFR 820 Subpart J

➢Information and resources

WHO SHOULD ATTEND

This webinar is an ideal presentation for those individuals in your organization involved in the following functions:

➢Quality compliance

➢Quality assurance

➢Quality engineering

➢Management representatives (to ISO and/ or FDA)

➢Quality systems change owners

➢Engineering management

About Your Instructor

William McQuillan is currently Global Manager Change Document and Record Management and CAPA Subject Matter Expert, Cordis, a Johnson & Johnson Company.

He has previously worked for LifeScan, a Johnson & Johnson Company. His experience includes working in CAPA, Product QA and Complaint Investigation departments.

Will considers deploying global CAPA solutions, improving cycle time and effectiveness of CAPAs in multiple operational companies, and developing international partnerships for the sustained success of a CAPA program to be significant accomplishments in his career to date.

He has conducted training for his company related to understanding CAPA, Good Manufacturing Practice practical applications, root cause investigation and the nonconformance process, and has been involved in multiple FDA inspections related to quality systems, including staging room management, front room auditee, and subject matter expert preparation.

➢This recording is now part of a CONTENT Package. Read more...