Effective CAPA – How the FDA Investigates Your CAPA System?
A SMART Approach To Implement, Execute and Manage an Effective CAPA!
Instructor :
Charles H. Paul
Webinar ID:
3356
Date: 7 September 22, WED
Start Time: 9 am PT
Duration: 90 Mins
What you will learn
- CAPA Defined
- CAPA Relevant Regulations
- Exception/Deviation Reporting
- CAPA Process Flow
- CAPA Process Steps Explained
- Challenges and Pitfalls of CAPA’s
- CAPA and Risk Mitigation
- CAPA Defined
- CAPA Relevant Regulations
- Exception/Deviation Reporting
- CAPA Process Flow
- CAPA Process Steps Explained
- Challenges and Pitfalls of CAPA’s
- CAPA and Risk Mitigation
Course Description
Inadequate failure investigations continue to be a major GMP deficiency and consistently make the FDA’s top 5 list for adverse observations.
How CAPA’s are executed and managed is crucial to maintaining a compliant organization. This course highlights:
- The various regulations governing CAPAs
- How CAPAs are successfully initiated and managed
- How an effective failure investigation and root cause analysis is accomplished.
The primary objective of this webinar is to heighten awareness of the importance of the proper execution of the CAPA process to the organization, to the efficacy of the product and the process, and to the safety of patients and customers.
Join Now!
Inadequate failure investigations continue to be a major GMP deficiency and consistently make the FDA’s top 5 list for adverse observations.
How CAPA’s are executed and managed is crucial to maintaining a compliant organization. This course highlights:
- The various regulations governing CAPAs
- How CAPAs are successfully initiated and managed
- How an effective failure investigation and root cause analysis is accomplished.
The primary objective of this webinar is to heighten awareness of the importance of the proper execution of the CAPA process to the organization, to the efficacy of the product and the process, and to the safety of patients and customers.
Join Now!
Why you should attend
During this webinar, emphasis is placed on the application and practical aspects of the process to include its critical steps, CAPA timing, participants to the process, roles and functions, and the pitfalls associated with CAPA investigations.
The content of the webinar will focus on the practical and how to best thoroughly accomplish an effective CAPA.
Join us to learn more…
During this webinar, emphasis is placed on the application and practical aspects of the process to include its critical steps, CAPA timing, participants to the process, roles and functions, and the pitfalls associated with CAPA investigations.
The content of the webinar will focus on the practical and how to best thoroughly accomplish an effective CAPA.
Join us to learn more…
Areas Covered
- CAPA Defined
- CAPA Relevant Regulations
- Exception/Deviation Reporting
- CAPA Process Flow
- CAPA Process Steps Explained
- Challenges and Pitfalls of CAPA’s
- CAPA and Risk Mitigation
- CAPA Defined
- CAPA Relevant Regulations
- Exception/Deviation Reporting
- CAPA Process Flow
- CAPA Process Steps Explained
- Challenges and Pitfalls of CAPA’s
- CAPA and Risk Mitigation
Who is this course for
Anyone involved in the manufacturer of pharmaceutical products, foods, beverages, cosmetics, and medical devices.
FUNCTIONS
- marketing
- research & development
- technical services
- manufacturing
- compliance and regulatory
- logistics/supply chain
- service and maintenance
POSITIONS
- Associates..
Anyone involved in the manufacturer of pharmaceutical products, foods, beverages, cosmetics, and medical devices.
FUNCTIONS
- marketing
- research & development
- technical services
- manufacturing
- compliance and regulatory
- logistics/supply chain
- service and maintenance
POSITIONS
- Associates
- Supervisors
- Managers
- Directors
- Vice Presidents
Instructor Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
