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This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.
Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.
Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.
A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.
Root cause analysis and corrective actions plans work well for solving quality problems, but how do you prevent quality incidences altogether? You have to dig deeper and investigate what David Manalan dubs the "real root cause."
Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).
Probably one of the most significant concerns for anyone responsible for implementing, deploying and maintaining a quality management system is the prioritization of resources. Trend analysis is one technique that can help determine if something has changed with a process (quality, production, or service). Trend analysis can be used to monitor a process, especially non-manufacturing processes such as complaints, nonconformances and deviations to aid in the decision for escalation for corrective and preventive action (CAPA).
It’s that time of year when we get together with family and friends and enjoy holiday festivities. Sure, all the mingling and merriment of a holiday party can be fun, but organizing an event—not so much. If you happen to be the designated planner/host of your holiday soiree, you may want to consider using an electronic quality management system (eQMS).
Industries and manufacturers are increasingly approaching the challenge of digital transformation, some with caution, some with great anticipation, yet perhaps still others with unease. However, the message in a recent analyst report “Quality 4.0: Get Educated Get Involved, and Build a Successful Strategy” is clear—transform your company’s operations and efforts digitally or risk digital disruption. Forty percent of companies have already started a digital transformation initiative while another 17 percent kicked off initiatives in 2017, according to the report, which was co-sponsored by LNS Research and MasterControl.
Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?
Humans will make mistakes. Industries have been focusing on strategies to reduce or even eliminate human error in efforts to keep consumers and employees safe. Pharmaceutical companies are responsible for ensuring that their products are safe, labeled correctly, have the correct strength, are pure, and are produced with good quality. In the pharmaceutical industry when deviations are identified as a result of an error, organizations follow a deviation investigation process to understand the root cause and put in a corrective action to fix the problem.
Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl, Inc.
It's been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal corrective and preventive action (CAPA) system to monitor and manage the safety complaints associated with their products. Yet, managing a CAPA system remains a major challenge for many manufacturers.A sound CAPA system organizes and evaluates complaints, nonconformances, and other deviations about products and services to improve patient safety. But the problem is: How do you
Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process is a major challenge for most medical device companies. This problem can be so overwhelming that an FDA official called it "death by CAPA."Is your CAPA system helping or "killing" your organization? In the next issue, an article by Ken Peterson, senior partner of PathWise Inc., a leading CAPA training and consulting provider, will examine ris
The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.
Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future? Those of us who have a wider view of what innovation should deliver seek entirely new approaches verses conventional problem-solving for cause. It’s not that analytical thinking is unnecessary but on occasion, a new solution unrelated to cause removal is warranted.
A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years. For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).
Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request?
Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).
A previous post to this blog covered some of the highlights of a recorded MasterControl webinar that discusses best practices for corrective and preventive action (CAPA) systems. The free recording is presented by quality expert Ken Peterson, a prominent consultant who has decades of experience with risk management, customer service, and CAPA systems. Peterson has devoted his quality expertise to a long list of successful companies such as Pfizer, Abbott Laboratories, Kodak, and IBM.
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