CAPA Training and Causes of Warning Letters due to Lack of Comprehension

Duration: 90 Minutes
A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system.
CAPA Training
Instructor: Jerry Dalfors
Product ID: 500282

"Proper" completion of the required forms in the "proper" order as described in the corporate directives and site procedures is what is required to remediate and prevent future observations by auditors and inspectors who have found numerous implementation issues and execution as result of variances in overall comprehension (failure to establish and maintain an adequate CAPA program). Examples are presented during the presentation.

CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet. The program to make effective corrections and ensure that preventative applications were incorporated was in use way back in the 60s by NASA and the FAA to enhance safety but was not labeled CAPA even though the intent was the same.

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?

Objectives of the Presentation:
  • PROPER Too often regulatory documents are written using subjective terminology and grammar (first person, pronouns and adverbs) instead of objective, technical descriptions of the element being addressed (stick to the facts). Lack of technical writing skills has contributed to the majority of the current submission rejections, 483s, warning letters and consent decrees - see FDA examples at end of presentation. GMP controlled documents must be written in a way that will be clear to the jury when presented in a court case, as opposed to writing like "we are having a conversation". Who in this case is "we", the head of quality or a janitor? How to determine if sources of product and quality information that may show unfavorable trends have been identified as well as confirming that data from tracking system, complaint handling or other sources are organized to identify potential product and quality problems that may require preventive action that would be easily understood by a third party reviewer (FDA inspector).
  • CAPA Implementing an effective corrective actions or preventive action capable of meeting QS Regulations and satisfying quality assurance and GMP/GDP documentation requirements is accomplished in nine basic steps. 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. Need to understand the difference between correction and corrective action.
  • Identification of the incident.- Criticality of the Incident Tracking System separate from deviation tracking.
  • 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.
  • 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 can Benefit:
Inspectors, Auditors, Quality and Documentation Personnel within the industry as well as Regulatory, Quality, Operations and Development

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Instructor Profile:
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. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
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