Taking the Mystery out of CAPA
Alan M Golden Overview:
Corrective Actions/Preventive Actions are an integral part of a robust quality system in both pharmaceutical and medical device manufacturing. The ability to be able to determine the root cause of a product or manufacturing issue and put effective corrections in place is critical to continued product quality. Understanding the process of root cause investigations and the appropriate corrective actions/preventive actions will help ensure continued product quality.
Why you should Attend:
CAPA is a required part of both pharma and medical device quality systems. An understanding of the CAPA system and putting into place a robust process will help ensure quality products and smooth manufacturing.
Areas Covered in the Session:
- Gain an understanding of the CAPA process
- Understand the need for CAPA
- Discuss inputs into the CAPA process
- How to put a good process in place
Who Will Benefit:
The following professionals in the Pharmaceutical, Medical Device, or Combination Product industries with responsibilities in the following areas:
- Quality Systems
- Quality Assurance
- Quality Control
- Change Control
- Engineering/R&D
- Regulatory Affairs
- Manufacturing
Speaker Profile
Alan M Golden has over 35 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 20 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.