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.
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
Salt Lake City, UT - Marriott City Center
Salt Lake City Marriott City Center
220 South State Street · Salt Lake City, Utah 84111 USA
1-801-961-8700
- 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
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