Corrective and Preventive Action (CAPA) is of the essence in any industry. The importance of CAPA is all the more pronounced in the life sciences industry, considering the importance of this discipline on human lives. It is the very core of a sound management system. CAPA, as the name suggests, is a set of preventive and corrective measures that need to be taken to ensure that the product meets its quality and regulatory expectations.
The essence of CAPA for the life sciences is that it should build the ability to respond to problems as they arise, but more importantly, a CAPA system should help the life sciences organization to anticipate and thus prevent problems from happening.
CAPA in the life sciences is an amalgamation of the following core ingredients:
o Change Control
o Continuous improvement
o Complaint management
o The need for understanding and implementing CAPA
CAPA is the very edifice of Quality Management. It is a sine qua non for meeting regulatory requirements. Its importance to the life sciences industry vis-à-vis the FDA can be gauged from the fact that in just four years starting 2012, the number of Warning Letters the FDA issued shot up by over 12 times. Understanding and implementing the right CAPA system is critical to meeting regulatory requirements and preventing such actions from the FDA.
Common pitfalls of CAPA implementation
Many life sciences organizations face a few obstacles when it comes to CAPA implementation. The most common ones among these are:
o Failure to achieve an integrated view of the whole process that can be managed from any source
o Lack of understanding of the highly intricate and difficult processes
o Not documenting every step of the CAPA process
o Lack of clarity between what a corrective and preventive action is
o Not implementing uniform process across the product’s or company’s numerous sites.
An important line of thinking that needs to go into approaching CAPA is that understanding failures is as important as understanding success of a product in the life sciences industry if it has to meet quality and regulatory requirements. Understanding and correcting problems before they become critical and impede the product’s progress are vital to ensuring quality and meeting regulatory requirements.
Given the extremely high importance CAPA has in the regulated industries; it is but natural that there are a number of regulations that govern this area of the life sciences. How does an organization get an understanding of these regulations right? How does it enforce these regulations in the right manner, so that its products meet the regulatory and quality requirements?
Learn to get these aspects right
All these will be the topic of a highly valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.
At this webinar, Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm, will be the speaker. To gain proper and complete insights into all the areas of CAPA for the life sciences, just register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501216?Wordpress-SEO
At this session, Charles will explain how to apply core aspects of the CAPA process that includes:
o The critical steps
o The timing of CAPA
o Who all in the organization need to take part in the process
o Their roles, responsibilities and functions, and
o The snags and hazards with CAPA investigation into the process.
The content of this webinar is designed to help participants achieve a highly effective CAPA system. It will help explain the purpose and function of CAPA, by which they will be able to:
o Identify and explain the relevant CAPA regulations
o Define exception/deviation reporting and explain the process of executing the reporting process
o Explain and trace the CAPA flow from problem identification to resolution
o Explain the challenges and pitfalls of the CAPA process and how they are overcome.
o Explain CAPA’s role in risk mitigation.
o Explain how root cause analysis is executed.
At this very valuable session, Charles will cover the following areas of CAPA for the life sciences:
o CAPA defined
o CAPA relevant regulations
o Exception/deviation reporting
o CAPA process flow
o CAPA process steps explained
o Challenges and pitfalls of CAPA’s
o CAPA and risk mitigation
o Root Cause Analysis.