If you are looking for the answer to these questions, you will certainly benefit from attending this seminar on preparing for FDA inspections:
• Do you worry about an upcoming FDA inspection?
• Do you know how you should behave during the inspection?
• Do you know what an end to end FDA inspection process looks like?
• Do you know what an FDA investigator(s) will look for?
• Do you know how to proactively assess and mitigate FDA compliance risks?
• Do you know what information you should get ready ahead of an FDA inspection?
• Does your organization have a game plan for managing an FDA inspection?
• Does your organization know how to respond to and manage FDA observations (483s), or warning letters?
• To provide an overview of the FDA inspection program and key success factors for a manufacturer.
• To introduce the best practices on how to manage inspections including a template of game plan.
• To introduce the industry best practices on what information should be prepared ahead of inspection including a checklist.
• To introduce the best practices including templates on how to respond to and closeout FDA 483s and warning letters.
• To introduce the best practices and toolkit on how to assess readiness for a FDA inspection, and how to proactively identify and mitigate compliance risks.
Who will Benefit
This course will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:
• Quality Engineers
• Managers • Directors
• VPs, Regulatory Affairs
• Auditors • Risk Managers
• Compliance Officers
• Management Representatives
• Management with Executive Responsibilities
• Members of Senior Management Team
• Validation Managers.
Additionally attendees will be provided with:
• Toolkit on how to assess a quality system’s readiness, and identify and mitigate potential compliance risks.
• A checklist of information that should be prepared prior to in
• Background about FDA inspection program.
• How to proactively assess quality system readiness for FDA inspection.
• How to identify compliance risks.
• How to proactively mitigate before, during and after the inspection.
• How to respond to 483s and warning letters including templates based on industry best practices.
Day ONE (08:30 AM to 05:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Welcome and Introductions (30 Minutes)
• FDA Inspection Program Overview (1.5 Hour)
Type of FDA Inspections
Outcome of Inspections
Potential business impact – Compliance Risks
• Key factors for a successful FDA inspection (0.5 Hour)
FDA investigator’s objectives
Key factors for a successful FDA inspection
• Quality System Readiness (2 Hours)
Quality Systems Readiness Assessment
Compliance Risk Identification and Mitigation
Plan of Mitigations
• Information Readiness (1 Hour)
Company and Organization information
Quality Systems Documents and Records frequently requested
• Organization Readiness (2 hours)
Game Plan: Front Room, Back Room, SMEs, Communications, etc. Facilities
Dos and Don’ts Class Exercise: Role Playing.
DaY TWO (08:30 AM to 02:30 PM)
Welcome (15 Minutes)
Manage FDA inspection Outcomes
Study of Examples: (1.5 Hours)
Example of 483
Example of EIR
Example of Warning Letter
Response and follow up management (1.5 Hours)
Follow up on EIRs
Manage Warning Letters
Final Q/A Sessions with the best FDA Speaker
Angela BazigosChief Compliance Officer Morf Media Inc.
Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in Virtual Validation of Software.