This CAPA training will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system.
Description
This presentation will begin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is “Corrective Action Preventive Action” otherwise referred to CAPA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/level will then ensue. Upon completion of risk part of the presentation we will define what a CAPA system would look like.
The presentation will focus on CAPA as it applies to risk mitigation. We will define what we mean by a CAPA system. We will further define the tools CAPA uses during implementation. Finally an overview of a CAPA system will be presented and a CAPA approach will be proposed. The approach will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. We will also review some of the benefits which may accrue by having a robust CAPA system in place.
Areas Covered in the seminar:
- What is risk? How to define the levels of risk?.
- What events may cause, or increase the potential of, risk?
- How does risk manifest itself?
- What are Nonconformances and Deviations? How to document a nonconformance/deviation?
- Evaluation and Risk Assessment of nonconformance/deviation, what information is needed to evaluate.
- How to address Deviations and Nonconformances within a CAPA program?
- How to Investigate and determine severity of nonconformance/deviation?
- How to track and dispose of nonconformances/deviations?
Who will benefit:
This program is designed to introduce technicians and professionals involved in the manufacture, packaging and storing of drug products to the fundamentals of Corrective Action Preventive Action as a risk mitigating tool. The discussions would be beneficial to personnel involved in the manufacture, compliance and engineering within biopharmaceutical operations. Professionals and technicians who should attend include:
- Technical Services
- Manufacturing and packaging
- Engineering
- Facilities Services and Maintenance
- Validation
- QA/QC
Instructor Profile:
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over 27 years of experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AICHE.
