CAPA Under the FDA Lens – How the FDA Investigates Your CAPA System?
Build An Effective CAPA Plan – From Problem Detection to Effectiveness Check!
Instructor :
Charles H. Paul
Webinar ID:
4787
Date: 12 April 23, WED
Start Time: 10 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
Processes of the life sciences regulated industries (the manufacturing of medical devices, biopharmaceuticals, and traditional drugs) are plagued with deviations and non-conformities.
Regulatory agencies perform thousands of inspections every year. Too often, investigation and CAPA system violations are at the top of the list.
Companies face many challenges in making the investigation and CAPA system work as intended.
Companies must ensure their investigation and CAPA system looks beyond product issues and considers other quality issues, including problems associated with processes and systems.
Unfortunately, many regulated companies are approaching the investigation and CAPA system very lightly, implementing corrections but no corrective and prevention actions.
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.
Enroll Now!
Processes of the life sciences regulated industries (the manufacturing of medical devices, biopharmaceuticals, and traditional drugs) are plagued with deviations and non-conformities.
Regulatory agencies perform thousands of inspections every year. Too often, investigation and CAPA system violations are at the top of the list.
Companies face many challenges in making the investigation and CAPA system work as intended.
Companies must ensure their investigation and CAPA system looks beyond product issues and considers other quality issues, including problems associated with processes and systems.
Unfortunately, many regulated companies are approaching the investigation and CAPA system very lightly, implementing corrections but no corrective and prevention actions.
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.
Enroll Now!
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
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- 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
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
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
- Supervisors
- Managers
- Directors
- Vice Presidents
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.
