5 Key Components of Good Manufacturing Practices to obtain cGMP certification
Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith currently works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.
Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the standards for a product to be deemed safe, pure, and effective. Good Manufacturing Practices are critical to any organization that produces products for the public. This training will discuss 5 key components of current Good Manufacturing practices. This training will be a generalized discussion for all FDA-regulated industries who need to meet cGMPs, this includes but is not limited to Pharmaceuticals, Medical Devices, HCT/Ps, Cosmetics, and Nutraceuticals.
Upon completion of this course, attendees should be able to identify and understand the following components to having a successful cGMP program
- Materials and products used in production.
- Facility requirements
- Resources such as people and equipment
- Effective processes
- Adequate documentation
Attendees will also understand Best Practices in a GMP facility as well as How to obtain cGMP certification if a facility chooses to do so
Course Level - Basic/ Fundamental
Who Should Attend
- Quality Specialists
- Quality Operations
- Quality Supervisors/ Managers
- Plant engineering
- QA/QC staff
- Process excellence/improvement professionals
- Process engineers
Why Should You Attend
Are you just starting in the FDA industry? Or maybe you have been there for a while but need some refresher training? Perhaps you want to get your facility GMP certified. This training is for you. We will go over the basic components needed for a facility to meet the FDA cGMP (current Good Manufacturing Requirements) and ways to obtain cGMP certification.