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GMP Certification Program Certified Quality Assurance ManagerSpeakersMarcus Heinrich B. Braun Messenger, GermanyDeviation Management and CAP Live Online Training on 14/15 June 2022Dr Ulrich Herbert Charles

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How to fill out deviation management and capa

01

Identify the deviation: Determine what went wrong in the process or product.

02

Record the deviation: Document all relevant details such as date, time, location, and individuals involved.

03

Investigate the root cause: Analyze why the deviation occurred and what factors contributed to it.

04

Develop a corrective action plan (CAPA): Create a plan to address the root cause and prevent future deviations.

05

Implement the CAPA: Put the corrective actions into place and ensure they are effective.

06

Monitor and review: Continuously monitor the effectiveness of the CAPA and make any necessary adjustments.

Who needs deviation management and capa?

01

Any organization that wants to maintain quality standards and regulatory compliance.

02

Companies in industries such as pharmaceuticals, biotechnology, medical devices, and manufacturing.

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What is deviation management and capa?

Deviation management is the process of identifying, investigating, and resolving deviations from standard procedures, while CAPA (Corrective and Preventive Actions) is the process of identifying and addressing the root cause of non-conformities to prevent recurrence. CAPA is often initiated as a result of a deviation.

Who is required to file deviation management and capa?

All individuals involved in the manufacturing, testing, and distribution of products are required to file deviation management and CAPA reports as part of the quality management system.

How to fill out deviation management and capa?

Deviation management and CAPA reports should be filled out by documenting the deviation or non-conformity, investigating the root cause, implementing corrective and preventive actions, and verifying their effectiveness.

What is the purpose of deviation management and capa?

The purpose of deviation management and CAPA is to ensure that any deviations from standard procedures are promptly addressed, root causes are identified and corrected to prevent recurrence, and overall product quality and safety are maintained.

What information must be reported on deviation management and capa?

Deviation management and CAPA reports should include a description of the deviation or non-conformity, root cause analysis, corrective and preventive actions taken, and verification of their effectiveness.

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