Many peoples speak about 21 CFR part 11 compliance. But need to understand more about the contents of e-CFR. The Electronic Code of Federal Regulations (e-CFR) is a web version of the Code of Federal Regulations (CFR) that FDA update daily to better reflect its current status. The e-CFR is an editorial compilation of CFR material and amendments published in the daily Federal Register.
As, it is required to understand the requirements for electronic records and electronic signatures, it is mandatory to understand requirements of 21 CFR Part 11, e-CFR & EU GMP Annex 11
Course Objective:
- During webinar, we will make you aware about the e-CFR.
- This webinar will make you understand the requirements of 21 CFR Part 11, e-CFR & EU GMP Annex 11 under one umbrella
- The webinar will trigger the process of awareness about the current state/level of GMP compliance of the organizations.
- These activities can safeguard the organizations from product failure to negative actions by the regulatory agencies.
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- IT Departments
- Documentation Departments
- Supply Chain Departments
- Auditors
ICT105