Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

Date : 24th March 2021 to 24th March 2021

Place : United States, East Camden

Website :https://worldcomplianceseminars.com/

Contact Person:WCs Conference

Description:

CAPA ( Correcive and Preventive Actions) for FDA regulated arena such as Medical Device, Food and Pharmaceutical industries is getting a lot of attention today by FDA and ISO auditors. CAPA requirements have been tightened for ISO 13485: 2016 requirements.CAPA has been heaviliy scrutinized by FDA for 21 CFR 210/211 and 820 to deal with non conformances in quality systems. Several FDA findings have been cited for inadequacy in quality management systems as FDA 483s and Warning letters. This is because it has been found to be very challenging to understand and fulfil the FDA CAPA needs for medical devices and drug manufacturers and by the suppliers to these industries. In the current environment of global standardization of quality and regulatory needs, learning to understand and interpret the risk based FDA’s CAPA regulatory requirements for medical device and drug companies and fulfilling them is extremely important. Strong CAPA documentation will lay the foundation to bullet proof FDA audits of your quality systems. This webinar will provide a step by step approach and valuable tips for understanding the CAPA requirements from a regulatory point of view and setting up your CAPA system and CAPA records for your Medical Device, Food and Pharmaceutical world. CAPA is a key area that has several prescriptive documentation requirements for its various phases. This will be discussed step by step and simplified during this webinar.

Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries will be held in East Camden,United States on date 2021-03-24

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Deadline for abstracts/proposals : 24th March 2021

Keynote Speakers : Meena Chettiar, has worked as a Scientist for Health Canada and as a Quality Management Professional in food, pharmaceutical and medical device industries for over 25 Years in Canada and the United States. During this time Meena has had the opportunity to be audited by the US FDA several times answering questions on Quality Systems requirements.

Conference Highlights :Will review FDA CAPA definitions and expectations based on her personal experience in closing several CAPAs in FDA regulated industries Will incorporate several examples based on the FDA CAPA Requirements so you can integrate them into your product risk management for commercialization Will discuss pathways for successfully interpreting regulatory expectations for CAPA procedure, and incorporating Problem statement, RCA, Investigation and VOE documentation under the quality management systems

Check the event website for more details.