Learn Effective and Efficient system of Purchasing controls.
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 Purchasing Controls, Receiving Inspection, and Supplier Audit! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control. You’ll learn about the essential elements of purchasing control and how you can translate them into your procedures. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
Supplier Audits are an important part of ensuring the use of acceptable suppliers. This important task has become more difficult during a global pandemic. This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits remotely.
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
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.
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations
Webinar Takeaway
This 90-minute webinar will focus on establishing an effective and efficient system of purchasing controls. Topics to be covered include:
· Understanding the regulations
· Lessons Learned
· FDA Expectations
Authority and Scope
Balance between Supplier Control and Receiving Acceptance
· Purchasing Controls Process
Planning
Evaluation of Suppliers
Purchasing Data
Performance Management
Feedback and Communication
· Supplier Audits
· Quality Agreements
· Best Practices
Who Will Benefit from this Medical Device Training Online
Medical Device Companies :
- Supplier Engineers
- Supplier/Purchasing Managers
- Quality Engineers
- Supplier Quality Engineers
- Compliance Personnel
- Supplier Auditors
- Compliance Specialists
Susanne Manz
Consultant | Educator | Author
Baltimore, Maryland Area
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification from RAPS and Quality Auditor Certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals