Regulators require manufacturers of pharmaceuticals and medical devices to assume responsibility for the quality of all supplied products and services.

Establishing and maintaining your supplier Quality Assurance (QA) program is a challenge with regulatory requirements and supply chain complexity continuing to increase.

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Content

This course will provide you with an overview of the current regulatory requirements and expectations, along with a 6-step plan for managing your supplier quality so you can start reducing your supplier risks and improving your compliance. You will get an appreciation for:

  • Recent changes and enforcement trends in regulatory requirements for supplier management: FDA, EMA, TGA
  • Regulatory and industry guidelines including TGA, ASMI, IMDRF (formally GHTF) and APIC
  • SOPs and records needed for compliance and to prove effective supplier qualification.
  • Six step plan for managing supplier quality:
    1. Planning
    2. Selection of potential suppliers
    3. Evaluation and acceptance
    4. Establishing controls
    5. Delivery, measurement and monitoring
    6. Feedback and communication
  • Identifying supplier risk factors
  • Establishing supplier risk ratings and evaluation criteria
  • Structure and content of the Supplier Quality Agreement
  • Reduced testing considerations
  • When the supplier is part of your organisation – Quality Agreements and the role of QA
Participants

This course is designed for key quality and operational personnel (supervisors and managers) who are involved in supplier assurance implementation.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training can be delivered as 2 x 3.5 hour sessions over 2 days or as 1 full day session. Breaks are included.

PDF Certificates will be provided to participants electronically.

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions