GMP Professional Certification

GMP PROFESSIONAL CERTIFICATION FULL 10 COURSE PROGRAM

Take advantage of pre-enrollment savings by registering for the ENTIRE 10 COURSE program now only $2050. No application process or additional fees.

Click "Register Now" to Begin.

The GMP Professional Certification Program will provide the necessary orientation and understanding of the USA FDA’s Current Good Manufacturing Practices for pharmaceutical products. The program will cover techniques and practices to ensure compliance with these regulations including manufacturing, packaging, holding, distribution, and the laboratory. It will provide a practical application of the cGMP on the operating level.

The Certified GMP Professional is an individual trained in the understanding and interpreting of the FD&C Act, the cGMPs, the FDA Guidance Documents, and the FDA’s recent Observations issued in FD 483’s to pharmaceutical firms.

The Certified GMP Professional should be able to:

• Demonstrate a good working knowledge of Good Manufacturing Practices (GMP’s) for drugs and international standards and regulatory requirements – as applicable.

The GMP Professional Certification recognizes that the Candidate has completed and demonstrated proficiency in each of the required series of online courses. The distinction of a GMP Professional can differentiate the candidate from others in their industry.

The GMP Professional Certification Program consists of a total of 10 intensive, 90-minute sessions, a total of 15 contact training hours. Candidates must complete and score at last 80% in the Learning Assessment* for each course.

Required Series of Online courses:

• Scope of the FDA – History and FDA Regulations
• 21 CFR 211 Subparts A & B: Quality and Personnel
• 21 CFR 211 Subparts C & D: Facility and Equipment
• 21 CFR 211 Subparts E & F: Control of Components and Production/Process Control
• 21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
• 21 CFR 211 Subparts I: Laboratory Controls
• 21 CFR 211 Subparts J &K: Records and Salvaged Drug Product
• FDA Quality Systems Guideline
• cGMP Compliance and non-Compliance
• cGMP Compliance - Process Validation