Overview: CAPA Implementing an effective corrective or preventive action capable of meeting QS Regulations and satisfying quality assurance and GMP/GDP documentation requirements is accomplished in nine basic steps:
Identification of the incident.
Evaluation of the impact or magnitude of the incident
Initiation and Risk Assessment to demonstrate compliance with Quality Systems Regulations
Investigation procedure to assess various strategies in accordance with current regulatory expectations.
Root Cause Analysis avoiding subjective thinking to generate objective documentation
Action Plan generation listing the tasks, metric applications and acceptance criteria for each activity
Implementation Plan needed to accomplish the Corrective or Preventive Action Plan
Verification using stand alone documentation practices of for objective evidence to meet cGMP regulations.
Effectiveness monitoring plan to demonstrate the corrective action and/or preventive action is performing as anticipated preventing reoccurrence or initial occurrence of the identified issue.
The order of the listed activities is critical and all too often not followed in the specified sequence which has a negative effect when CAPA systems are inspected
Why Should You Attend: A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation and effective means of assessing various elements of CAPA expectations for products produced and distributed under the FDA regulations.
How do you know that your CAPA system procedure(s) that address the requirements of the quality system regulation have been technically defined, documented and implemented to determine if appropriate sources of product and quality problems are being identified and that the data from these sources are being analyzed and documented in an easy to understand technical report to identify existing product and quality problems that may require corrective action and/or preventative action?
Areas Covered in the Session:
How to verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems and determine if the results of analyses are compared across different data sources to identify and develop the extent of product and quality problems
How to determine if routine company procedures as well as failure investigation procedures have been effectively implemented and are being followed (re-training is NOT an acceptable routine corrective action for operator errors) as well as how to assess if the degree to which quality problems or nonconforming products requiring an evaluation and an investigation is investigated commensurate with the significance and risk of the nonconformity along with patient risk. If the evaluations or investigations are conducted to determine root cause, how do you ensure the accuracy of the conclusion, since so many times the corrective action has been shown to be ineffective as noted in the 483 observations. Of course our quality systems must demonstrate that we are preventing distribution of nonconforming product.
So what are we doing to determine if appropriate actions have been taken for significant product and quality problems as identified by our quality system incident tracking system?.
How are we demonstrating that our corrective and preventive actions were going to be effective and verified or validated prior to implementation (initiation of the change control)? We have to confirm that corrective and preventive actions do not adversely affect the finished device or impact what was submitted in our regulatory submission.
Examples of how successful companies have verified that corrective and preventive actions for product and quality problems were implemented and documented in accordance with FDA expectations.
All the above help us to determine and demonstrate that our data associated with nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.
Who Will Benefit:
Regulatory Affairs professionals
Quality System Auditors
Jerry Dalfors Mr. Jerry Dalfors has extensive (40 years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages.
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