Remote Auditing of Medical Device Suppliers During Covid-19

Kelly Thomas
Mar 18, 2021 - 01:00 PM
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The Covid19 pandemic has caused sudden disruption to the supplier management programs for many medical device companies. This webinar will help you update your approach to supplier auditing during the challenges of Covid19.

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for supplier audits and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.

You’ll learn about the essential elements of supplier audits. We’ll discuss the process steps for supplier control and how it relates to other parts of your QMS including receiving and acceptance activities. A well-designed supplier audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.


Course Objectives:

• Responsibilities for supplier management and purchasing controls

• Balance between supplier management and receiving inspection

• Enforcement case studies and lessons learned

• Quality agreements

• Using a structured program to identify areas of risk leading to an effective audit strategy

• When and how to conduct supplier audits

• How to develop a meaningful structure of oversight, audit, transparent communication, and escalation to management review

• Audit planning, execution, and follow-up

• How to ensure management gets valuable information from your audit program


Why Should You Attend:

Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.

The Covid19 pandemic has created unique challenges for medical device companies to audit their suppliers. Supplier management requires clear information about your supplier’s strengths and weaknesses and the capability to consistently meet your requirements. And without an effective supplier audit program, supplier management lacks awareness of the issues within their suppliers. Management is blind to the problems with its suppliers and the risks that pose.

However, many companies conduct audits only because they are required to by regulation. Businesses often see supplier audits as a non-value-added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having a supplier audit program, management is often surprised by quality problems. This webinar can help you to avoid these problems.


Course Outline:

•  Understanding the regulations and expectations

•  Lessons Learned

•  Purchasing Controls Process

•  Evaluation of Suppliers

•  The balance between purchasing control and receiving inspection

•  Which suppliers need to be audited

•  Auditing Criteria

•  Auditing Process

•  Remote Auditing during Covid19

•  Performance Management

•  Feedback and Communication

•  Best Practices

•  Inspection Readiness


What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points


Who Will Benefit:

•  Supplier Engineers

•  Supplier Auditors

•  Supplier/Purchasing Managers

•  Quality Engineers

•  Supplier Quality Engineers

•  Compliance Personnel

•  Compliance Specialists

•  Quality/Compliance managers or directors for Medical Device companies

•  General Managers wanting to learn how to Management Review and expectations

Webinar Events
Attend Live Webinar
Mar 18, 2021 - 01:00 PM

Duration: 90 Minutes

Single Attendee

Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version

Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Kelly Thomas, Vice President, Americas Quality Operations

Ms. 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.

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