Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)

Duration: 90 Minutes
While there is very little disagreement about the importance of controlling suppliers and contractors, quality problems and compliance issues attributed to supplier/contractor failures continue to be very problematic in our industry.
Purchasing Controls for Suppliers and Contractors
Instructor: Howard T Cooper
Product ID: 500402

Some reasons this problem exists include lack of understanding of the process and its requirements, fragmented procedures that do not consider the logic and flow of the processes as a whole, the failure to understand the interdepartmental tasks and responsibilities, and the failure to communicate the requirements to the supplier or contractor. These failures are frequently seen in FDA 43 citations and warning letters. Senior Management can see the impact on profit and customer satisfaction.

The FDA continues to place a high priority on quality failures attributed to supplier/contractor failures caused by supplier/contractor provided components and products. The root cause is a failure of the company to control the supplier and contractor. In May 2013, the FDA published the quality agreement guidance on the requirements for quality agreements. While this may clarify some compliance issues, more understanding of quality systems is required to sufficiently address these issues.
  1. Introduction, Purpose, and Objectives
  2. Basic Regulatory and ICH/IMDRF (Was GHTF) Requirements for Suppliers and Contractors-Similarities and Differences
  3. FDA Guidance 5/24/2013-Contract Manufacturing Arrangements for Drugs: Quality Agreements
  4. The structure of your supplier and contractor is impacted by your organizational structure
    • The brick-and-mortar company
    • The combination brick-and-mortar and virtual company
    • The totally virtual company
  5. Organizing and Establishing the Supplier/Contractor Qualification and Control Program
    • Roles and Responsibilities
    • Requirements
    • Objectives
    • Procedures
  6. The Entire Supplier and Contractor process will be flowcharted and visually describing the flow beginning with the developmental specification to through the commercial process.
    • Determining criticality of the specification and or requirements to determine approval strategy
    • Qualifying the supplier’s samples and associated test methods if applicable
    • Determining the qualification requirements-no audit, a virtual audit, or on-site audit
    • Selecting the audit team and audit preparation
    • Conducting the audit and evaluating the audit results
    • Writing and sending the report and handling the supplier response
    • Follow-Up and monitoring
    • Qualifying for reduced testing
    • Disqualifying the supplier
  7. The Changing Supplier/Contractor Paradigm and the Future
Why Should you Attend:
Whatever your experience level is, this webinar will help you understand the entire lifecycle of suppliers and contractors. They gaining an understanding of the processes, you can compare your processes to the processes described in this webinar. You’ll see the strengths and weaknesses of your own processes so that you may build on the strengths and improve the weaknesses. The result will be a more effective operation.

Objectives of the Presentation:
  • To clearly define the regulatory requirements for incoming material controls and suppliers/contractors.
  • To introduce quality concepts and principles outside the regulations that improves supplier/contractor control and effectiveness
  • To provide a perspective on the FDA guidance “Contract Manufacturing Arrangements for Drugs: Quality Agreements”, May-2013
  • To enhance the understanding of the supplier-contractor lifecycle by using flowcharts describing the logical inputs and outputs of the process
  • To describe the “What & How” for establishing a program for effectively controlling suppliers and contractors
Who can Benefit:
  • For those whose include responsibilities and tasks related to materials, materials testing, and working with suppliers and contractors, this webinar will provide new perspectives and suggestions for improving your existing program.
  • For those new to these task and responsibilities, you’ll begin to understand the processes and their requirements and see a logical flow of relationships between elements so that you can begin to make immediate contributions to the organization.
  • For others, it will broaden your understanding of the material and supplier/contractor quality systems so that you may explore new areas of quality and develop your professional skills and abilities.
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. After leaving the brewing industry, he joined a medical device contractor when the Medical Device Amendments were being finalized. His first challenge was to establish a GMP system that met the needs of the large medical device clients that contracted with the company to produced finished medical devices. This very successful challenge led him to focus on startup quality systems and to mitigate failing quality systems.

His experience includes:
  • Designing and implementing Quality Systems from scratch in several startup operations.
  • Managing both single and multiple site quality operations
  • Assisted in revamping failing quality systems under warning letters and consent decrees
  • Advised large FDA regulated companies to improve their quality operations.

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