In today’s heavily regulated life sciences industry, ensuring pharmaceutical quality is of utmost importance. The FDA closely regulates pharmaceutical manufacturing, and compliance with their Current Good Manufacturing Practice (cGMP) regulations is essential.
For professionals in the pharmaceutical, medical device, and cosmetics industries, obtaining a GMP Professional Certification from COBBLESTONE can provide the necessary orientation and understanding of the FDA’s regulations for pharmaceutical products. Our latest certification program covers a range of techniques and practices to ensure compliance in various aspects of the industry, including manufacturing, packaging, holding, distribution, and laboratory work.
Click here to learn more and register to become a GMP Certified Professional
Our exclusive 10-part certification program will cover everything you need to know about cGMPs and how they apply to the pharmaceutical industry. You’ll learn about FDA enforcement and how companies can comply with these regulations. We’ll go through the FDA regulations 21 CFR 211 Subparts A through K and explain their meaning as they relate to the US pharmaceutical industry. You’ll learn how to interpret these paragraphs and ensure compliance. We’ll also discuss the FDA Quality Systems Guideline and how to comply with it. Additionally, we’ll address compliance with the FDA GMPs, including aspects of compliance and non-compliance. Finally, we’ll discuss the FDA guide on process validation and its meaning as it applies to the US pharmaceutical industry. The course will provide an explanation of the concepts and aspects of compliance to the guideline.
Demonstrate your proficiency in cGMP regulations, show your commitment to quality in the industry, and gain the knowledge necessary to ensure compliance and improve overall industry standards. Don’t miss out on this valuable opportunity to advance your career.
The certification will cover the following areas:
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