Management of an Effective CAPA

Why do so many companies struggle internally with their CAPA (corrective/preventive action) program?
As with other regulations, US FDA sections 21 CFR Part 211.160, 192, 810.100 have good definition, but it’s up to companies to apply the requirements and then put their own approach and rationale together for a compliant CAPA program.
Therein lies the issue, how do we interpret the regulation, develop the procedure and then get our internal teams to respond in a timely fashion? There are many FDA inspection instances where either lack of a CAPA program or severe deficiencies in the CAPA process including failure to close in a timely manner or an improper effectiveness check is cited.
In this webinar, we will explore the basis and development of a good CAPA program including what critical quality oversight and management review should entail. We will also explore the 7 tenants of a good CAPA process including:
Identification of the issue,
Evaluation of the problem,
Investigation of the failure,
Analysis of the root cause,
Approval of mitigation including both corrective and preventive activities,
Implementation of the action plan,
Managing the effectiveness check follow up.
If your company is struggling with internal CAPAs, please plan on attending this informative webinar.
Tim Bio
Tim has been in the Life Science compliance arena for 30 years. Beginning his career at Abbott Laboratoris in North Chicago Illinois USA in lab operations, manufacturing and technical support, he was able to build on that experience and spent several years as Director of Compliance for 3 different contract manufacturing organizations. He then began working directly with compliance software platforms including Compliance Quest, Pilgrim, ETQ and PrisymID as an Industry SME and now manages a consulting group focused on Quality 4.0 software initiatives, GMP quality systems/auditing and FDA/Supplier remediation.