Testing Method Selection, Specification Setting & Equipment Qualification

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

Salt Lake City, UT - Marriott City Center

• Walk to Temple Square, shopping & dining from this AAA 4-diamond Salt Lake City hotel
• Named as one of the best Salt Lake City hotels for quality and service
• Free high-speed Internet access, award-winning service, 15,000 sq ft of event space

Venue Address and Contact Details

Salt Lake City Marriott City Center
220 South State Street ·
Salt Lake City,
Utah
84111 USA

Tel: 1-801-961-8700

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 experts for this course are:

• Kerri LeVanseler
  Ph.D.
  Technical Manager, Chemistry Laboratories, NSF International

  • [email protected]
  • +1 857 350 4788

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.