Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. 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:
- Clearly defined specifications/requirements for all of these goods or services being purchased, and;
- Objective evidence to show that your requirements are being consistently fulfilled.
It is designed for those who already have a basic understanding of dietary supplement GMPs and the knowledge and skills necessary to qualify suppliers.
Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the auditing process and the skills and techniques needed to get the most from these activities. The skills and techniques learned are independent of the type of auditing or the standard being audited and will be useful when conducting internal audits and performing audits of suppliers.
Why Should You Attend
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.
Learning Objectives
On conclusion of this course, you will have an understanding of the following:
- Regulations that apply to vendor qualification (21 CFR 111)
- Food Safety Modernization Act (FSMA)
- Impact of FSMA on Supplier Qualification
- Risk assessment and risk management
- Supplier monitoring activities
- On-site audit strategies and requirements
- Managing the audit process effectively before, during, and after
- The consequences of non-compliance
8.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 8 credits towards a participant's RAC recertification upon full completion.
Course Content
Agenda - Day 1
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
