Objectives of the Presentation
Upon completion of this program you will know:
- What are Good Laboratory Practices
- Why were they created
- What is the objective of GLPs and how are they associated with GMPs and SOPs
- Statistical procedures for data evaluation
- Instrumentation validation
- Analytical and laboratory certification
- Documentation and maintenance of records
- Consequences of noncompliance
- Disqualification and reinstatement
Why Should you Attend:
Periodically one hears the comment that 'a laboratory or a manufacturing facility meets 21 CFR Part 58 and therefore they meet the entire cGMP requirements.' Contrary to popular belief, 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and do not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not 'watered down' GMPs.
Good Manufacturing Practice (cGMPs) represents that part of Quality Assurance that ensures the products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification. Non-Clinical laboratory studies (58.1) support or are intended to support application for research of marketing permits for the following products to include:
- Food and color additives
- Human and animal drugs
- Medical devices for human use
- Biological Products
- Electronic Products
GLPs do not include manufacturing product. Non -clinical Laboratory Studies (58.3) include in vitro or in vivo experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects or clinical studies or field trials in animals.
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
- GLP is an FDA Regulation
- Definition of GLPs
- History of GLPs
- Why was GLP Created?
- Objectives of GLP
- Mission of GLP
- Instrumentation Validation
- Analyst Certification
- Laboratory Certification
- Grounds for Disqualification
- Consequences of Noncompliance
- Reinstatement of a Disqualified Facility
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.
During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.
The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
Principle Consultant ,
Maynard Consulting Company
Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.
Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.
Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing.
- Quality Control Personnel
- Research and Development Personnel
- Regulatory Affairs Personnel
- Project Managers
- Manufacturing Managers
- Validation Engineers
- Internal Auditing Personnel
- Microbiology Personnel