Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) is a seminar that addresses quality and GMP compliance requirements for virtual companies in the pharmaceutical, medical device, and biologics industries, focusing on regulatory expectations and effective oversight of outsourced operations.
Key Topics
- Selection, qualification, and monitoring of CMOs, CROs, and contract laboratories
- GMP and GCP requirements for virtual companies
- Quality agreements and technical agreements
- Data integrity and regulatory obligations
- Inspection management and logistics
- Responding to document requests and inspection observations
- Applicable FDA, EMA, and Health Canada procedures
- Determining relevant GMP and GCP requirements based on internal vs. outsourced activities
Who should Attend
- Quality professionals
- Senior quality managers in manufacturing QA/GMP or clinical quality areas
- Clinical operations personnel
- Regulatory professionals
- Quality auditors – GMP and GCP
- Compliance professionals
- Document control specialists
