CAPA Training and Causes of Warning Letters due to Lack of Comprehension
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.
"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"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).
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:
- 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.
Who Will Benefit:
- Inspectors
- Auditors
- Quality and Documentation Personnel within the industry as well as Regulatory
- Quality
- Operations and Development
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.