Testing Method Selection, Specification Setting & Equipment Qualification
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This course integrates relevant aspects of 21 CFR 111, ICH and USP guidelines as well as best industry practices.
Tuesday 12 to Thursday 14 June 2025
Carlsbad, California
$1,595.00 per delegate
$1,435.50 (Early bird booking)
Type: Dietary
About this course
This training program is designed to provide education and training to Quality Assurance/Quality Control personnel and others involved in the dietary supplement industry to facilitate not only regulatory compliance but also to develop world-class quality systems.
The training integrates relevant aspects of 21 CFR 111, ICH and USP guidelines as well as best industry practices. Specifically and practically, the training addresses critical aspects of dietary supplement matrix complexity, modern analytical testing tools, specification setting, test method selection to satisfy “fitness for purpose”, equipment qualification and quality infrastructure issues, test method design to ensure that a method is “scientifically valid”, implementation of test methods, and post-“validation” activities.
Who Should Attend
The training is designed for senior QA/QC managers, R&D managers and personnel, product developers, analytical method developers and laboratory personnel, quality system auditors and staff, and regulatory personnel.
Course outline
- Matrix complexity
- Current analytical methodologies and tools
- Testing categories and strategies
- Instrument qualification
- Understanding the Certificate of Analysis (C of A)
- Specification setting
- Sampling
- Method selection and fitness
- Understanding the validation elements
- Developing the validation plan and acceptance criteria
- Infrastructure: personnel, laboratory, and SOPs
- Post-“Validation”: Change Control and Charting
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