About this course
Every system has things that do not go according to plan and results that do not meet expectations. A cGMP system will have many sources of such issues: customer complaints, product non compliances, internal deviations from specified practices, supplier problems, and results from internal, second-party or third-party audits. This course will focus on factors and techniques to enable you to turn these initially negative events into positive outcomes that will not only avoid recurrences of these problems, but strengthen your overall quality system.
Who Should Attend
This course is a must for employees at all levels involved with any activities associated with manufacturing, packaging, labeling or holding dietary supplements; as well as employees involved with the activities of quality control, quality assurance, packaging, labeling, and distributing dietary supplements in the U.S.
How to Book
To book this course, please, do not go through the book now on the right of the screen – follow this link instead:
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Course outline
What You Will Learn
- Scope and sources / inputs to an effective CAPA system within the FDA-regulated dietary supplement context
- Factors to help move your CAPA system toward being less reactive and
more proactive
- Common problems (and solutions) associated with implementing and maintaining effective CAPA systems
- How the FDA concept and tools of risk management relate to effective CAPA
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods will provide delegates with plenty of time to obtain answers to their specific questions and concerns.
Venue
Las Vegas, NV - Prior to SupplySide West
The Venetian Hotel
3355 Las Vegas Boulevard South Las Vegas, NV 89109
(702) 607-7777
Tutors
Your trainer for this course has been specially selected for her extensive experience in compliance of GMPs in the dietary supplement industry. Nicole has worked for NSF-DBA as a subcontract trainer and GMP consultant for a year. Nicole is a Senior Partner at Validation & Compliance Institute where she has led regulatory projects for many clients, both large and small since 2002. She has held many management positions in FDA-regulated industries, including three Vitamin production facilities at BASF. She serves as an expert witness. She is a member of ASQ and the American Chemical Society. Nicole Leitz received her ACS certified BS degree in chemistry at Hope College in Holland MI, and a MS in theoretical organic chemistry at Bucknell University under Harold Heine, PHD.
What you've said
“NLI is always working to implement the most stringent quality systems and looking for opportunities to prove the superiority of its systems. DSQP certification with NSF-DBA has been another way for NLI to show a commitment to being a CMO of the highest quality. Investment in training ensures your company is in compliance and manufacturing safe products for the public”
Jera’le Smith, Director of Quality Assurance, Nutritional Laboratories International (NLI)
“I attended both NSF-DBA’s FDA inspection Readiness and Corrective Action Management modules and our company assiduously implemented the recommendations made. I am absolutely convinced that doing so was one of the primary reasons our company did not receive an FDA Form 483 following an FDA unannounced 4-day GMP inspection”
Kim Randall Pearson, General Counsel, Thorne Research, Inc.
An NSF International Company
