Good Manufacturing Practice (GMP) Compliance Program
$ 150
Provides a thorough grounding in Good Manufacturing Practices as applied in pharmaceutical, biomedical, and medical device manufacturing contexts.
Course Description
This program provides a thorough grounding in Good Manufacturing Practices as applied in pharmaceutical, biomedical, and medical device manufacturing contexts. Participants learn to implement and audit GMP systems that assure product quality, safety, and regulatory compliance.
Program Modules
- Introduction to GMP: History, Principles & Regulatory Framework (WHO, ICH, FDA)
- GMP Documentation: SOPs, Batch Records, Specifications & Logbooks
- Personnel Requirements: Training, Hygiene & Qualification
- Premises & Environment: Design, Cleaning & Environmental Monitoring
- Equipment Qualification: IQ, OQ, PQ & Calibration Programs
- Process Validation, Change Control & Deviation Management
- Quality Control in Manufacturing: In-Process & Finished Product Testing
- GMP Audits, Regulatory Inspections & Corrective Action Management
Who Should Attend
Quality assurance officers, production managers, regulatory affairs professionals, laboratory scientists in manufacturing, and compliance auditors in pharmaceutical, biotech, and medical device industries.
Course Details
- Duration: 4 Days
- Investment: $150 per participant