Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset
Over 30 years of diverse international industry experience in Quality Assurance, Quality Control, and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma, and device industries.
- Experience has spanned from R&D to Commercial Manufacture
- Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species
- Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of a laboratory at a new site and forensic data integrity investigations
- Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control
- Expert level in Compliance and Quality System development
- Executed numerous Data Integrity assessments and remediation projects worldwide
- Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs
A discussion of the basic principles and requirements for Good Manufacturing Practices. The presentation provides a brief history and basis for the existence of GMPs, a discussion of what they cover, and examples of real-life situations along with a discussion of possible responses and the reasons one or more responses may be appropriate or not.
- Fundamental requirements of Good Manufacturing Practices (FDA based)
- Overview of the laws and regulations
- Discussion of the scope of the requirements
- Basic Principles the GMPs require
- For each of the parts of 21 CFR 211, will describe the scope and extent
- Examples: organization and personnel direct how you dress, requirements for your health, how you move through the facility, that you have a unique, verifiable identity, etc.
- Examples: What a typical facility might look like – different classifications, different flows, different access levels
- Records – If it's not documented, it didn’t happen
- Principles of Data Integrity – ALCOA
- Learning how to approach operations from a compliance mindset to ensure success in any situation – 4 examples of situational ethics – how do you respond appropriately.
- Good Manufacturing Practice fundamentals
- GMP principals
- Data Integrity Principals found in GMPs
- Summary of specific areas covered throughout GMPs
- Case Study example scenarios with a discussion of best answers
Course Level - Basic/Fundamental
Who Should Attend
- Students preparing to enter into regulated environments
- New Employees
- Refresher for All Levels
Why Should You Attend
Persons new to the industry or planning to enter the regulated pharmaceutical/biopharmaceutical industry. Equally valuable as a refresher. Working in a regulated industry requires a specific mindset. Too often personnel don’t understand the necessary mindset or don’t follow the necessary mindset either out of ignorance or other factors. Add value to your resume, ensure you have the right mindset.
In this webinar you will learn not just what is required, but how to think and operate to ensure you meet the intent of regulations applicable to the pharma/biopharma industry. We will translate the regulations into practical English – what do they mean? We will also explore different scenarios with possible actions and discuss the appropriateness or lack thereof for each action.