CAPA Training Overview
Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems
Do you know Deviations and Non-conformances are enviable. The key is utilizing those events as an avenue to improve the overall quality system. Thorough Root Cause Analysis is essential to correcting and preventing issues. RCA is a systematic approach that utilizes quality tools to objectively identify factors that have resulted in or could contribute to a deviation.
Once the RCA identifies the factors that caused the event, proper generation of CAPA actions is critical to maintaining a healthy quality system. The regulatory agencies fully expect to see documented root cause analysis that resulted in both corrective and preventative actions.
Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar
Q&A from the last session
Why is it important to determine a root cause?
It is important because you are going to use that root cause to put corrective action that would personally prevent that from happening again. So root cause is very important in understanding the process and also helps in order to prevent it from happening again in future.
Webinar Takeaway
Part 1 – How to Perform a Thorough Root Cause Analysis (RCA) 60 minutes
• Understand Regulatory and Industry Guidance
• What is Root Cause Analysis?
• When Should Root Cause Analysis be performed?
• Discuss several Root Cause Analysis Methodologies
• Discuss common errors that occur during RCA
Part 2 – Developing Appropriate Corrective and Prevention Actions (CAPA) 60 minutes
• Understand Regulatory and Industry Guidance
• Discuss the difference between Correction, Corrective Action, and Preventive Actions
• Understand How to Develop robust CAPA records; including effectiveness checks
Part 3 – Review Real Life Case Studies 60 minutes
• Discuss recent Regulatory observations in regards to insufficient investigations and CAPAs records.
Who will Benefit from this CAPA webinar
- Operations
- Facilities
- Engineering
- Quality Assurance
- QC Managers
- Quality Engineers
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.