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