Training Overview

This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry.

This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.

Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the Contract Manufacturing Organization (CMO). CMO’s must be selected following a rigorous formalized procedure.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Complimentary Hand-outs:

For easy implementation, attendees will receive:

  • 6 page CMO pre-audit quality survey form
  • 25 page CMO audit survey form

Webinar Takeaway

  • CMO management principles
  • Supplier quality categories
  • Approved Vendor List (AVL)
  • Phases of CMO selection from initial telephone inquiry to quality survey to qualification audit
  • Planning a qualification audit-establishing evaluation team
  • Conducting a qualification audit-key points to evaluate
  • Decision factors for selecting a CMO-key practical points
  • Distinctive technical competence
  • Optimum CMO size
  • Risk of educating future competitor
  • Key points for the contract
  • Change approval by both CMO and company
  • Quality agreement
  • Dealing with uncooperative suppliers

Who will Benefit

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Engineering Departments
  • Research and Development Departments
  • Validation Departments
  • Project Managers
  • Software Developers
  • Global Contract Manufacturing Transfer Teams
  • Those that use contract manufacturing and contract testing facilities
  • Microbiology Professionals
FDA Faculty Edwin Waldbusser

Edwin Waldbusser

medical device design control, software validation, artificial intelligence, and risk management consultant (FDA and EU MDR)

Mount Arlington, New Jersey, United States

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Choose a Purchase Option


$229

Live Webinar - Single Participant

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$499

Live Group Up to 5 Participants + 12 month access

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded Access is Included

$695

Live Group Up to 10 Participants + 12 month access

You get 10 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded access is included

$399

Recorded Access Single Participant

You'll have 12 month single user access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$899

Recorded Access Corporate Group

You'll have 12 month group access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

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

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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