BPEC Competency Challenge - Regulation & Quality
The Regulation & Quality Badge certifies that the recipient has a comprehensive understanding of the regulatory environment and quality practices in biotechnology. This includes knowledge of CGMP, GDocP, and compliance with FDA guidelines. Recipients are familiar with the processes involved in product development, regulatory approval, and maintaining data integrity and security.
Skills / Knowledge
- Regulatory compliance and CGMP
- Good Documentation Practices (GDocP)
- FDA approval process and bioprocessing
- Data integrity and security
- Quality control and assurance