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
For easy implementation, attendees will receive:
- 6 page CMO pre-audit quality survey form
- 25 page CMO audit survey form
- 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
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.
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology 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 NIH, EMA, 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 Compliance, Process 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.