ComplianceOnline, Online Event
2011-02-15
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. Why Should You Attend: Medical Device Companies are using different tools to identify and manage the risks but sometimes companies lack the over all process to connect the dots. This gap has resulted in several field failures and significant recalls of the products due to inappropriate prioritization of risks involved. ISO 14971 provides a comprehensive model to not only identify the risk, but also to prioritize and mitigate the risks to as low as reasonably possible. The scope includes the entire product realization process including the afterlife disposal of the devices. This 3.5 hr webinar will discuss the key elements of the risk management process, FDA recognized risk management model and how to connect different activities to better understand the product and process risk and risk mitigation. Learning Objectives: - FDA recognized Risk Management Model
- Detect risks early in the Design & Development phase
- Improve product performance by mitigating risks
- Helps differentiate your product from the competition
- Helps the team and management talk the same language
- Effective way to prioritize the risks
Areas Covered in the Seminar: - Risk Management Plan
- Risk Analysis (Intended Use, Identification of Hazards, Estimation of Risks).
- Risk Evaluation.
- Risk Control (Risk Control Option Analysis, Implementation of Risk Control Measure(s), Risk/benefits analysis)
- Evaluation of overall residual risk acceptability
- Risk Management Report
- Production & post-production information
Who Will Benefit: - R&D Engineers / Managers
- Quality Assurance Personnel
- Regulatory Affairs Personnel
- Advanced Manufacturing Personnel
- Manufacturing /Operations Personnel
- Consultants
- Quality System Auditors
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Invited Speakers:
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Jasmin NUHIC, serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn. Salim Khan, 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 risk management and design control 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.
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