Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) is a conference that provides knowledge on how to select, qualify and monitor CMOs, CROs and Contract Laboratories.
Topics
- How to select , qualify and monitor CMOs, CROs and Contract Laboratories
- GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations
- How to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource
- The elements to include in a quality agreement (also known as a technical agreement)
- The importance of maintaining data integrity
- Your obligations under the law for products you release to the clinic or the marketplace
- Inspection logistics
- How to effectively manage a health regulatory inspection:
- Managing the inspection exit discussion
- Responding effectively to document requests and questions from inspectors
- How to find applicable inspection references and procedures of the FDA, EMA and Health Canada
- How to write an effective response to inspection observations
Who should Attend
- Quality professionals
- Senior quality managers in manufacturing QA/GMP or clinical quality areas
- Clinical Operations
- Regulatory professionals
- Quality auditors – GMP and GCP
- Compliance professionals
- Document control specialists
