Medical Device Process Validation Training for Professionals

Comply Rules

Date: Mar 8, 2023.Time: 1 PM - 2:30 PM ETDuration: 90 MinGroup Packages: Please contact sam@complyrules.comThis 90-minute session on risk-based verification and validation planning will discuss &quot;must have&quot; elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management and show how you can integrate these into a company&#x27;s quality management system.Why Should You Attend:FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in verification and validations. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based process V&amp;V planning / execution. Consider some basic principles in the FDA&#x27;s Process Validation Guidance Document for pharma. The &quot;must have&quot; elements from ISO 14971(and ICH Q9) for hazard analysis and product / process risk management. Integration of process validation essentials into a company&#x27;s quality management system.This webinar will review company&#x27;s Process Verification and Validation system for major cGMP deficiencies. Address the FDA&#x27;s newer and tougher regulatory stance, and its most recent Process Validation guidance upgrade (device principles from pharma). One major failing is lack of sufficient or targeted risk-based V&amp;V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations.It will also discuss the roles of different V&amp;V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Our matrix examples simplify &quot;as-product&quot;, in-product&quot;, process and equipment, et al, software VT&amp;V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 and cybersecurity are considered.Areas Covered in the Webinar:Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also, to be discussed is how to tackle process validation for medical device combination products.<ul><li>Assurance of product quality from CGMP compliant validation</li><li>Learn how to improve process system knowledge and understanding.</li><li>Learn methods for developing process validations and best practices.</li><li>Understand the scope of regulations governing process validation and identify gaps.</li><li>Develop a plan to rectify existing validation plans, protocols and reports.</li><li>Learn how to construct, implement and deploy a Validation Master Plan</li></ul>Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to review and modify their Process Validation Planning and Execution / Documentation. While this information is focused on Medical Devices, its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:<ul><li>Senior management</li><li>Regulatory Affairs</li><li>Quality Assurance</li><li>Production</li><li>Engineering, including Software.</li><li>All personnel involved in verification and/or validation planning, execution and documentation.</li></ul>Additional service: (Personalized session)We also do various similar customized events for our clients, and it is specially tailored as per the client&#x27;s requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP, GLP, 21 CFR, Computer system validation, FDA Audit &amp; Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost-efficient program for you.

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Medical Device Process Validation Training for Professionals

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Medical Device Process Validation Training for Professionals

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