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.
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
Carlsbad, California
Hyatt House Carlsbad (formerly known as Summerfield Suites)
Hyatt House San Diego/Carlsbad
5010 Avenida Encinas
Carlsbad, California 92008
United States
Located on the coast of beautiful Carlsbad, California and conveniently situated only 2½ blocks from the beach, HYATT house™ San Diego/Carlsbad is surrounded by the area’s many great attractions. Enjoy a five-minute shuttle ride to Legoland or the Village of Carlsbad or travel a short 35 miles to the San Diego Convention Center, SeaWorld, San Diego Zoo, San Diego Wild Animal Park, Old Town or the San Diego airport.
Hotel Accommodations
For more information on special room rates, please contact the Hyatt House at 760-929-8200 and mention NSF-DBA training. Special rates may be available for up to 30 days in advance of the training session.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
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