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Elements of Current Good Manufacturing Practices (CGMP) for Biomanufacturing
Understand the fundamentals of current Good Manufacturing Practices (CGMP) for Biomanufacturing. CGMP exists to protect the health and safety of patients or consumers.
This course covers current regulations found in the selections of 210/211 of Title 21 of the Code of Federal Regulations (CFR) as well as the relevant ICH and FDA guidance documents.
Expand your knowledge. Apply CGMP in biopharmaceutical production.
This course may be taught at any location.
Level: Beginner
Lecture Hours: 16.00
Lab Hours: 0.00
Total Contact Hours: 16.00
Currently Offered
Elements of Current Good Manufacturing Practices (CGMP) for Biomanufacturing - Class begins August 7, 2019
Topics Include
This 2-day, 16-hour course covers the following topics:
- Buildings and Facilities
- Equipment
- Equipment Maintenance, Cleaning and Calibration
- CGMP Validation
- Cleaning Validation
- Production and In-process Controls
- Materials Management
- Packaging and Labeling
- Laboratory Controls
- Personnel
- Complaints and Recalls
- Change Control
- Computer Systems
- Drug Product Regulations
Learning Objectives
- Explain the pharmaceutical industry’s good manufacturing practices.
- Discuss the importance of maintaining a contaminant-free environment.
- Define quality and discuss how quality products are important for safety and efficacy.
- Describe the essential items identified by the Code of Federal Regulations and CGMP.
- Explain validation principles and their importance to the industry from a quality perspective.
- Discuss the consequences of good and poor quality.
Audience
This course equips professionals whose responsibilities depend on operating in CGMP and regulated facilities, including:
- Manufacturing Technicians
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Maintenance / Engineers – aseptic emphasis
- Future Medical Device Industry Employees
