Vendor Qualification and Audit Training

Seattle, WA
Thursday, June 28, 2018
Vendor Qualification and Audit Training
Thursday, June 28, 2018 8:30 AM - 5:00 PM (Pacific Time)

Seattle, WA
US, HS, DS, VQ, CR
TBD
Seattle, WA, Seattle WA
United States

Map and Directions
DS- Vendor Qualification and Audit Training 
Cost: GMP Client $700/ NON GMP Client $1000


About This Course 
Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. The FDA does not provide much guidance on how to qualify vendors. This class is designed to give people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, 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 process of auditing and the skills and techniques necessary to get the most from these activities. The auditing skills and techniques learned in this course are independent of the type of auditing or the standard being audited. These skills and techniques will be useful when conducting internal audits as well as performing audits of suppliers

The course is interactive, with hands-on exercises including case-studies from recent Warning Letters. Bring your questions and prepare to interact with the instructor and your peers in the industry.

As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. A Certificate of Attendance will be provided upon completion of the course.

Who Should Attend?
Anyone from:  
     • Management
     • Manufacturing
     • Quality Control/Assurance
     • Packaging
     • Marketing
     • Laboratory Operations
     • Auditing
     • Suppliers and Distributors
     • Regulatory Affairs
     • Purchasing
     • Product Development

Class Length:              One day
Course Prerequisites: Participants should have taken NSF’s 21 CFR 111 Dietary Supplement CGMP Overview or equivalent

Course Outline
At the conclusion of the course participants will have an understanding of the following: 
    • The regulations that apply to vendor qualification
o 21 CFR 111
o Food Safety and Modernization Act
    • The consequences of noncompliance
    • The impact of FSMA on supplier qualification
    • Risk assessment and risk management 
    • Pre-qualification activities to focus your efforts
    • Verification of supplier data
    • Quality Agreements and other contracts
    • The top ten items that dietary supplements manufacturers are cited for and…
    • Supplier monitoring activities
o change control 
o re-qualification
o performance monitoring
o disqualification
    • Onsite Audit Strategies & Requirements
o FSMA Audit Requirements
o Key personal characteristics and interpersonal skills
o Tools and techniques to make auditing more effective
o Aligning audit activities with the right goals and objectives
o Process and system focus in auditing
o Managing the audit process effectively – before, during, after
    • Tools and Reference Materials
o SIDI working group efforts and how and when to use them
o Guidance Documents

Benefits of taking this seminar:
    • Find out what FDA is focusing on today
    • Your specific questions can be discussed
    • Avoid getting Warning Letters
    • Network with other professionals in the industry
    • Learn best practices from the instructor and other participants

Instructors:
TBD

Discounts Offered: 

10% if 3 or more persons from the same organization registers for a class

10% if a registrant completes all courses being offered at a location

15% if 3 or more persons from the same organization takes all classes being offered at a location


 

Contact Information

  • Phone: 800-NSF-MARK x5600
    dstraining@nsf.org


Payment Instructions

  • Payment Policy: 
    Payment for public courses is due upon registration. Course registration is not official until payment is received. NSF International accepts Visa, MasterCard and American Express. If another method of payment is required, please contact 800-NSF-MARK, x5600. 

    Travel Arrangements: 
    Lodging and travel costs are not included in the course fee. The individual attending the course must make their own travel arrangements. 

    Cancellation/Transfer Policy: 
    Substitutions are welcome anytime; however please notify us as soon as possible to make the necessary changes 

    Early Cancellations:
     More than two weeks, prior to the course date will be issued a refund less a 25% processing charge.

    Late Cancellations: Less than two weeks prior to the course date are not issued a refund

    Program Cancellation:  NSF Health Sciences Dietary Supplement Program reserves the right to cancel or postpone a course due to unforeseen circumstances. Should this occur, you will be notified as soon as possible. All efforts will be made to notify participants at least two weeks before the scheduled events. If NSF Training & Education cancels a course, your entire registration fee will be refunded


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