Why Should You Attend:
CAPA is the most cross-functional of all subsystems of your QMS. Firms have different CAPA processes which utilize different definitions and terminology for the same meanings. Having advance knowledge and awareness of what to expect during the FDA inspection will drastically assist your firm in the ability to anticipate the inspector’s questions, and how to “translate” your CAPA system into what the inspector is looking for.
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 straightforward proven recommendations how your company can use that same document in your preparation.
Agenda
- 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
Speakers
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.Who Should Attend
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
