About this course
Although Cleaning Validation is not required by 21 CFR 111, the principles applied in the pharmaceutical and biotech industry can be a useful tool to the dietary supplement industry to ensure the prevention of cross-contamination and potential adulteration.
Therefore, the skills obtained in this course will ensure that cleaning methods implemented in your facility will prevent the potential carryover of product, cleaning agents, impurities and potential contamination of harmful agents.
Who Should Attend
The training is designed for QA/QC managers, R&D managers and personnel, product developers, analytical method developers and laboratory personnel, quality system auditors and staff, and regulatory personnel.
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
- The requirements for cleaning/sanitizing
- Terms relevant to Best Industry Practice for Cleaning (Validation)
- Selection of cleaning and sanitizing agents
- Establishing acceptance criteria for cleaning system verification
- Identifying the documentation necessary to support consistently, effective, and compliant cleaning and sanitizing
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
