Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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: