How to Decommission a Medical OEM Molding Operation and Transfer it to a ''World Class'' Medical Contract Manufacturer
Instructor:
Rob Braido
Product ID: 702447
- Duration: 60 Min
Why Should You Attend:
The medical industry is in transition. OEM's are in the process of transferring more product and operations to contract manufacturers. Some OEM's and contract manufacturers are struggling with how to deal with these transfers and validation standards.
This medical device webinar will provide valuable assistance and give a process and procedures to all regulated companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will guide you on how to choose the right world class contract manufacturer. It will also cover how important a master validation plan is to meet today’s standards for the FDA and CE Mark.
The presenter will use a case study-approach to guide you in the procedures and process of transferring equipment, systems and processes to meet the evolving standards for the medical industry. With the regulations for quality and validations getting more stringent with every transfer, it is imperative that companies are armed with the skills to plan and execute equipment, tools and process transfers properly. This is a step-by-step process to guide you in your transfer. It will follow a recent successful case study in the medical industry.
Areas Covered in the Seminar:
- Should a medical company decommission and/or transfer an operation to a world class contract manufacturer.
- Gap analysis.
- Choose a world class manufacturer.
- Cost of validation.
- Risk plan.
- Contract negotiation.
- Master validation plan.
- Mold and component transfer.
- Pitfalls.
- Successful transfer.
Who will Benefit:
This webinar will provide valuable assistance and give a process and procedure to regulated companies to either keep operations inside or transfer equipment, molds, dies, systems and processes to a contract manufacturer.
- Plant managers and operation personnel in the medical industry (OEM's and suppliers)
- Project management teams
- Strategic supply chain teams
- Manufacturing engineers
- R&D, product development engineers and managers associated with validations
- QA, Regulatory Affairs and team members
- Validation specialists
- Business Development teams
- Corporate auditors
- Private equity firms
- Consultants
Mr. Robert Braido, has 35 years of experience in the medical industry. He is presently the principle at Visionary Consulting LLC and has been consulting with medical OEM's and suppliers to the medical industry for over 5 years.
Mr. Braido's has a broad breath of industry experience in prototype/product development, global strategic/tactical planning, technical due diligence/gap analysis, engineering and strong leadership skills to help develop new products and businesses. He has had great success working at Ethicon Endo-Surgery a J&J Company, Teleflex Medical, The Tech Group and Baxter Healthcare with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the SPE Medical Division for over 10 years and elected Chairman of the Medical Division.
Mr. Braido was selected as a member of a Johnson & Johnson Integration Team that took a small fledgling company with totally new products, technologies and structure from $75 million to $850 million in 5 years. His career is built on the ability to motivate, lead and coach people in different disciplines throughout the medical industry. The key factor has been driving creativity and innovation.
While working for J&J he was elected, as the Consortium Chairman for the Government Reinvestment Program along with MIT, the National Science Foundation and seven leading Fortune 200 companies to commercialize emerging technologies.
He has published numerous technical and leadership papers and articles. In the past thirty years he has been invited to share his experiences at a number of technical conferences and symposiums on presentations relating to the medical industry on prototype/product development, due diligence/gap analysis, project management, innovation and creativity.
More Training By Experts
- Bringing Compliance To Design Control For Older Products
- Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and Surgical Instruments
- Conformance of Design History Files for Mature Medical Devices
- Top 10 Medical Device Regulations Training (10 Courses)
- Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (8 Courses)
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
