Book Online Tickets for How FDA Trains its Inspectors to Review , Palo Alto. 
How FDA Trains its Inspectors to Review CAPA, and Best Practices for Inspection Preparation

 


This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspec

How FDA Trains its Inspectors to Review CAPA, and Best Practices for Inspection Preparation

 

  • One Dial-in One Attendee

    Sale Date Ended

    USD 199
    Sold Out
  • Group-Max 10 Attendees or Location

    Sale Date Ended

    USD 529
    Sold Out
  • 1x Person - Unlimited viewing for 6 Months

    Sale Date Ended

    USD 249
    Sold Out
  • One CD or USB is for usage in one location only

    Sale Date Ended

    USD 349
    Sold Out
  • LIVE + RECORDED VERSION

    Sale Date Ended

    USD 349
    Sold Out
  • LIVE + TRAINING CD or USB

    Sale Date Ended

    USD 449
    Sold Out

Invite friends

Contact Us

Page Views : 1

About The Event

How FDA Trains its Inspectors to Review CAPA, and Best Practices for Inspection Preparation

 
This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.

Why Should You Attend:

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for?

This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

Areas Covered in the Webinar:

  • Documents Used by FDA Inspectors
  • Operations Manual (IOM)
    • CAPA Implications, by Section
      • Requirements
      • Recommended Methods of Compliance for Each Requirement
  • CPG Manual 7382.845
    • CAPA Implications, by Section
      • Requirements
      • Recommended Methods of Compliance for Each Requirement
  • QSIT Manual
    • Description of each CAPA Inspectional Objectives
    • Description/explanation
    • Recommended Methods of Compliance

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • CAPA Coordinators
  • Executive Management
  • R&D management
  • Regulatory management
  • QA management
  • Consultants
  • Quality system auditors

Instructor Profile:

Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Mr. Kasoff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For 13 years prior to that, he served as director of regulatory affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Mr. Kasoff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. He received his Regulatory Affairs Certification in 1996.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.