Many companies depend upon a vendor or supplier for some product or service and need to ensure compliance. At the end of the day if the manufacturer fails to ensure oversight of the vendors they will be held responsible.
Manufacturers are responsible for ensuring the quality and integrity of their product and its components. We will review challenges one may encounter with the vendor qualification program including disqualification and how to handle those issues.
We will discuss a risk-based strategy to help ensure your vendors are in compliance with the regulations and you are receiving the quality products the first time.
In addition, this strategy will help eliminate the unfit vendors before going onsite and spending wasted time in a qualification audit. Make sure you are not losing money with poor performing vendors by qualifying them in advance and continuing to evaluate performance.
Why Should You Attend:
Time is money and costly delays from vendors/suppliers can be painful. Work to avoid these challenges by having a strategic risk-based vendor qualification program. Make sure your vendor requirements, are well vetted in advance and avoid wasting time and money on vendors that will not be able to perform.
Do you have back-up vendors in place in the event something would go wrong for all your critical supplies? How fast can you qualify a new vendor selection process?
Areas Covered in this Webinar:
We will discuss the process for a compliant vendor/supplier program. This includes having a risk-based approach to auditing your vendors and the selection process
We will discuss the assessment process including pre-approval with the use of surveys and how to re-assess vendors
We will review the different types of vendors and the frequency one may consider evaluating them
We will highlight various challenges one might have with the vendor qualification process and how to resolve them
We will address quality agreements and supplier agreements covering potential pitfalls
Disqualification of vendors will also be addressed
We will also review examples of warning letters from the FDA on regulations and regulatory compliance
Describe the requirements for a compliant vendor/supplier program
Discuss how to apply a risk-based approach to the supplier/vendor selection process
Discuss the process for supplier assessments, pre-approval, and re-assessment
Discuss quality agreements and supplier agreements
Discuss how to handle problem vendors and disqualifying a supplier/vendor
Who Will Benefit:
Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc., with over 20 years of experience in the pharmaceutical and medical device industry. She is also faculty for both graduate and undergraduate studies at the University of Phoenix.
In addition to a bachelor’s degree in biochemistry and molecular biology, she has an MBA, a doctorate in organizational management with a focus on leadership, and holds certifications from the American Society of Quality (ASQ) as a Certified Quality Auditor and a Six Sigma Black Belt.
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