This course is designed to help in creating an environment of preparedness and a culture of quality assurance by raising the awareness of FDA compliance in regulated facilities. Maintaining current knowledge of preparation steps, do’s and don’ts, documentation completeness and thoroughness, and an understanding of real-time preparedness can help to reduce employee stress during an actual audit. This course equips professionals who will experience FDA audits to maintain 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
- Faculty
- Review of the FDA’s mission.
- What is the FDA inspecting?
- Understanding key roles and responsibilities for inspection.
- What should be on your checklist for preparation of an inspection?
- Importance on internal audits.
- Inspector roles and rights during an inspection
- Inspection reporting and enforcement
- Activities include group discussion about inspector’s duties, review what the inspector found during inspections of companies, how to prepare for an audit or inspection.
- Attain an understanding of the importance of both internal audits and external inspections.
- Describe the relationship between FDA inspection activities and CGMP compliance through the Code of Federal Regulations (CFR) for pharmaceuticals.
- Identify inspection findings from real FDA inspections of companies.
- Explain do’s and don’ts for preparing for a FDA inspection.
- Distinguish the roles of company representatives during an inspection.
- Relate the importance of proper documentation to provide evidence of compliance with CGMP.
- Perform an audit of a document used in the biopharma industry
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.
This course is designed to help in creating an environment of preparedness and a culture of quality assurance by raising the awareness of FDA compliance in regulated facilities. Maintaining current knowledge of preparation steps, do’s and don’ts, documentation completeness and thoroughness, and an understanding of real-time preparedness can help to reduce employee stress during an actual audit. This course equips professionals who will experience FDA audits to maintain 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
- Faculty
- Review of the FDA’s mission.
- What is the FDA inspecting?
- Understanding key roles and responsibilities for inspection.
- What should be on your checklist for preparation of an inspection?
- Importance on internal audits.
- Inspector roles and rights during an inspection
- Inspection reporting and enforcement
- Activities include group discussion about inspector’s duties, review what the inspector found during inspections of companies, how to prepare for an audit or inspection.
- Attain an understanding of the importance of both internal audits and external inspections.
- Describe the relationship between FDA inspection activities and CGMP compliance through the Code of Federal Regulations (CFR) for pharmaceuticals.
- Identify inspection findings from real FDA inspections of companies.
- Explain do’s and don’ts for preparing for a FDA inspection.
- Distinguish the roles of company representatives during an inspection.
- Relate the importance of proper documentation to provide evidence of compliance with CGMP.
- Perform an audit of a document used in the biopharma industry
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.