warning letters ,Part 11,21 CFR Part 11, FDA Inspe 2011 - Medical Devices: Understanding Risk Management in Medical Devices

Discount : Get 15 % Discount as a early bird registrations. Use Promocode CGO15

During the webinar, we cover topics and provide examples and share personal experiences related to FDA and ISO 14971, Risk Management Process, Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post-Production, and more. We also provide number of questions and answers and give opportunity to ask specific questions related to the company/environment you serve.

Why Should You Attend

Risk management is NOT an option. It is must in the almost any environment, any industry and/or any company. Mistakes happen. Erros happen - both planned and unplaned for. Leearning is continuous. All more reasons to be better prepare to handle them and act on them to keep patients, doctors, machinist, operators, nuerses safe and companies healthy and profitable. Understanding risk management in medical devices is a must do for any professional serving medical industry in any format. Furthermore, risk management is a just good business sense as it tends to improve product reliability and durability and by that minimize warranty costs, recalls, bad press and more. Finally, ISO 14971 promotes good practices and processes necesary to ensure proper risk management is put in place - and it is effective. For all this and more, join us for this webinar and learn from our experiences, examples, as well as from the research we conducted in the area of risk management for medical devices.

"Attendees will receive free document - ISO 14971 and specific elements of FDA regulations"

Who Will Benefit

? Quality Manager
? Quality Engineers
? Product Developers
? Internal and external auditors
? Management Reps
? FDA inspectors
? Consultants

About Speaker

Experience in regulated (FDA) industry with vast experience in quality management systems, manufacturing and concurrent engineering, quality auditing, quality controls, supplier quality, supplier management, project management, training and management information systems (including development). Proven and verifiable track record in continuous improvement and cost saving initiatives (resulted in hundreds of thousands of dollars in savings and improved lead time). Enjoy leading teams, working with others and teaching part-time at a University.

Salim Khan- He holds a master degree in Manufacturing Engineering, an MBA and BS in Mechanical Engineering. He is also ASQ certified Six Sigma Black Belt, Certified Reliability Engineer, Certified Quality Engineer. Salim has successfully implemented several design control and risk management processes for medical device companies. He also has extensive experience in developing efficient product development process. He enjoys statistics and has completed several process validations.

Price List: Live : $189.00 Corporate live : $499.00 Recorded : $249.00, CD:$299.00
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