About this course
The FDA requires that manufacturers of dietary supplements must “qualify” each of their vendors but do not provide guidance on how a company is to perform this qualification. Supplier qualification principles also apply to subcontracted services affecting cGMP (manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.). Any supplier qualification program must include two critical components:
(1) Clearly defined specifications / requirements for all of these goods or services being purchased, and;
(2) Objective evidence to show that your requirements are being consistently fulfilled.
This course will offer guidance on how to achieve both of the above critical requirements in ways that will enable compliance with cGMP and make the most efficient use of your resources.
Since the evaluation of suppliers of all types often involves auditing, this course will also incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. These auditing skills and techniques are independent of the type of auditing or the standard being audited, so they will be useful to conducting internal audits as well as performing audits of suppliers.
Who Should Attend
This training course would be valuable to QA/QC, regulatory and compliance, laboratory, and other key personnel who are in charge of or a part of implementing a new or modifying an existing vendor qualification program into their dietary supplement companies’ operations. The course would also be useful for purchasing and production managers, who may be involved in the vendor determination process and could benefit from understanding some of the important elements in qualifying a supplier.
Course outline
What You Will Learn
Part I: Vendor Qualification
A What is required under GMP?
B. Where, When and How? Using Risk – Assessment and Risk Management in the vendor qualification process
C. Pre-qualification activities: defining your specifications and other requirements; quality system and cGMP requirements; obtaining and assessing data; using risk management principles
D. Verification of supplier data and obtaining objective evidence: supplier audits; verification of CoA data; fit-for-use confirmation; other sources of objective evidence
E. Quality agreements and other contractual agreements
F. Continuing activities: change control; monitoring performance; periodic re-qualification and re-verification activities
G. Disqualification and re-qualification
Part II: Effective, Value-Added Auditing
A. Important personal characteristics and interpersonal skills for successful auditing
B. Tools and techniques to make your auditing more effective
C. Aligning audit activities with the right goals and objectives
D. Process and systems focus in auditing
E. Managing the audit process effectively – before, during, and after
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
Venue to be determined.
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