'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 You Should 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.