Vendor Qualification and Audit Training (Prior to SupplySide West)

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.

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

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

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 his extensive experience in compliance of GMPs in the dietary supplement industry. Since 2005, Bill has been providing auditing services for NSF International of Ann Arbor, Michigan, to help them meet the needs of dietary supplement companies. Bill received a Bachelor of Science degree in chemistry from the Carroll College of Wisconsin and a M.S. Degree in Chemistry from the University of Wisconsin. Previous to working for NSF, Bill ran his own consulting, training and auditing business. Kracht was one of the first RAB-certified lead auditors in the United States and is a frequent speaker / trainer at several national and international quality conferences. He is also three-time past chairman of the International Conference on ISO 9000 and Related Standards.

• Bill Kracht
  BSChem, MSChem
  

  • [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.