Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff unique Read more
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company’s CAPA system. What will they look for?
Course Objective:
This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, 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 to increase the likelihood of a positive outcome during the inspection.
Course Outline:
• Documents Used by FDA Inspectors
• Investigations Operations Manual (IOM)
o CAPA Implications
o Recommended Methods of Compliance for each Requirement
• CPG Manual 7382.845
o CAPA Implications
o Recommended Methods of Compliance for each Requirement
• QSIT Manual
o Description of each CAPA Inspectional Objective
o Recommended Methods of Compliance
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• QA Management
• CAPA Coordinator
• Regulatory Affairs Management
• Executive Management
• Consultants
• Quality System Auditors
6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
LIVE : Scheduled on
17-May-2024 :11:00 AM EDT
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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : Scheduled on
20-May-2024 :01:00 PM EDT
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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
LIVE : Scheduled on
30-May-2024 :01:00 PM EDT
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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
LIVE : Scheduled on
18-June-2024 :11:00 AM EDT
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6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
LIVE : Scheduled on
19-June-2024 :11:00 AM EDT
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