FDA Audit Preparation

FDA Audit Preparation is designed to help create an environment of preparedness to instill a culture of quality assurance by raising the awareness of FDA compliance in regulated facilities. Preparation steps, do’s and don’ts, documentation completeness and thoroughness, and an understanding of real-time preparedness to reduce the stress during the actual audit is the primary goal of the course. In essence, this course equips professionals who will experience FDA audits to adequately prepare for compliance by following and documenting in accordance with CGMP.

Audience

Team Leaders and Supervisors
Regulatory Personnel
Quality Control Personnel
Quality Assurance Personnel
Manufacturing Technicians
Administrative Personnel (scribes)
Maintenance / Engineers

Topics Include

Reasons/Importance for Audits
What is Fair Game for an Audit
Preparing for an Audit
Do’s and Don’ts
Company Responsibilities
Preparation Activities and Documentation
Review of 483s and Warning Letters
Things to Know About an FDA Audit
What to expect
Auditor Roles & Rights
Auditor Responsibilities
Review of Sample Documentation

Learning Objectives

Attain an understanding of the importance of audits, both internal and external
Clarify the relationship between FDA auditing activities and CGMP compliance through the Code of Federal Regulations for pharmaceuticals.
Identify actual audit findings from other company inspections.
Explain do’s and don’ts for FDA audits.
Demonstrate the roles of company representatives during an audit.
Relate the importance of proper documentation to provide evidence of compliance with CGMP.
Perform an audit of a document used in the biopharma industry.