2024 Process Validation Essentials: Adapting to the FDA’s Latest Standards
Seamlessly Incorporate Risk Management And Data-Driven Decision-Making Into Advanced Process Validation!
Instructor :
Jose Mora
Webinar ID:
10975
Date: NOV 26, 2024 (TUE)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
What you will learn
-
- Global Harmonization Task Force Requirements (Includes FDA And ISO)
- Design Qualification
- Facilities And Utilities
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Typical Process ….
-
- Global Harmonization Task Force Requirements (Includes FDA And ISO)
- Design Qualification
- Facilities And Utilities
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Typical Process Validation Protocols
- Strategies For Achieving A Robust And Reliable Process
Course Description
- Facing challenges with integrating real-time data analytics into your process validation protocols amid shifting FDA regulations?
As regulatory landscapes evolve, staying ahead requires not only compliance but a strategic edge in employing cutting-edge technologies.
Join us for our webinar on “Process Validation Requirements and Compliance Strategies”—a comprehensive session designed for professionals in the LifeScience industry.
This webinar will provide you with essential insights and up-to-date strategies for ensuring your process validation not only meets FDA regulations but also contributes to more robust and efficient production systems.
Course Highlights:
- Understanding Process Validation Basics: Dive deep into the fundamentals of process validation, learning how to transform standard procedures into a competitive advantage for your organization.
- Beyond Compliance: Emphasize moving beyond mere compliance to achieve enhanced process reliability. Discover how a well-executed process validation can lead to increased consistency, improved yields, and significant reductions in operating expenses.
- Latest Industry Trends: Get insights into the latest trends and updates in process validation, including the use of real-time data analytics to monitor process effectiveness and the integration of risk management principles according to the latest FDA guidelines.
- Interactive Case Studies: Engage with real-world scenarios that demonstrate the successful application of advanced process validation techniques in high-stakes environments.
- Q&A Sessions: Have your specific questions answered by our industry experts who bring years of practical experience in FDA-regulated settings.
This webinar is tailored to equip you with the knowledge and skills necessary to ensure that your process validation efforts are not only compliant but also optimized for maximum efficiency and effectiveness in today’s dynamic market.
Join Now!
- Facing challenges with integrating real-time data analytics into your process validation protocols amid shifting FDA regulations?
As regulatory landscapes evolve, staying ahead requires not only compliance but a strategic edge in employing cutting-edge technologies.
Join us for our webinar on “Process Validation Requirements and Compliance Strategies”—a comprehensive session designed for professionals in the LifeScience industry.
This webinar will provide you with essential insights and up-to-date strategies for ensuring your process validation not only meets FDA regulations but also contributes to more robust and efficient production systems.
Course Highlights:
- Understanding Process Validation Basics: Dive deep into the fundamentals of process validation, learning how to transform standard procedures into a competitive advantage for your organization.
- Beyond Compliance: Emphasize moving beyond mere compliance to achieve enhanced process reliability. Discover how a well-executed process validation can lead to increased consistency, improved yields, and significant reductions in operating expenses.
- Latest Industry Trends: Get insights into the latest trends and updates in process validation, including the use of real-time data analytics to monitor process effectiveness and the integration of risk management principles according to the latest FDA guidelines.
- Interactive Case Studies: Engage with real-world scenarios that demonstrate the successful application of advanced process validation techniques in high-stakes environments.
- Q&A Sessions: Have your specific questions answered by our industry experts who bring years of practical experience in FDA-regulated settings.
This webinar is tailored to equip you with the knowledge and skills necessary to ensure that your process validation efforts are not only compliant but also optimized for maximum efficiency and effectiveness in today’s dynamic market.
Join Now!
Why you should attend
The pace of regulatory changes in the LifeScience industry can be daunting. With new FDA guidelines being frequently introduced, it’s crucial to stay informed and adaptable.
Attending this webinar ensures you are up-to-date and ready to implement the latest requirements effectively.
- Navigate Regulatory Complexities with Confidence: Learn how to apply the Global Harmonization Task Force standards, including nuanced FDA and ISO regulations, to your processes. This knowledge is vital to maintaining compliance and avoiding costly penalties.
Enhance Your Operational Excellence: In this competitive market, operational inefficiencies are more than just a nuisance—they are a threat to your business’s viability. This training will equip you with strategies to:
- Optimize Process Validation: Reduce variability and enhance consistency, which can lead to improved product quality and lower production costs.
- Implement Advanced Analytical Techniques: Utilize cutting-edge data analytics to monitor and adjust processes in real-time, ensuring optimal performance and compliance.
Solve Real-World Problems: Through practical examples learn how to apply theoretical knowledge to real-world scenarios. This hands-on approach helps bridge the gap between theory and practice, enhancing your problem-solving skills and making you a more effective leader in your field.
- Interactive Learning Experience: Engage with experts and peers to discuss challenges and solutions, further enriching your learning experience and providing you with actionable insights you can immediately apply.
Enroll Now!
The pace of regulatory changes in the LifeScience industry can be daunting. With new FDA guidelines being frequently introduced, it’s crucial to stay informed and adaptable.
Attending this webinar ensures you are up-to-date and ready to implement the latest requirements effectively.
- Navigate Regulatory Complexities with Confidence: Learn how to apply the Global Harmonization Task Force standards, including nuanced FDA and ISO regulations, to your processes. This knowledge is vital to maintaining compliance and avoiding costly penalties.
Enhance Your Operational Excellence: In this competitive market, operational inefficiencies are more than just a nuisance—they are a threat to your business’s viability. This training will equip you with strategies to:
- Optimize Process Validation: Reduce variability and enhance consistency, which can lead to improved product quality and lower production costs.
- Implement Advanced Analytical Techniques: Utilize cutting-edge data analytics to monitor and adjust processes in real-time, ensuring optimal performance and compliance.
Solve Real-World Problems: Through practical examples learn how to apply theoretical knowledge to real-world scenarios. This hands-on approach helps bridge the gap between theory and practice, enhancing your problem-solving skills and making you a more effective leader in your field.
- Interactive Learning Experience: Engage with experts and peers to discuss challenges and solutions, further enriching your learning experience and providing you with actionable insights you can immediately apply.
Enroll Now!
Course Agenda
-
- Global Harmonization Task Force Requirements (Includes FDA And ISO)
- Design Qualification
- Facilities And Utilities
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Typical Process Validation Protocols
- Strategies For Achieving A Robust And Reliable Process
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- Global Harmonization Task Force Requirements (Includes FDA And ISO)
- Design Qualification
- Facilities And Utilities
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Typical Process Validation Protocols
- Strategies For Achieving A Robust And Reliable Process
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody Benefits from Watching This. Even Better When Done as a Group!
- Quality Assurance Manager
- Quality Control Supervisor
- Regulatory Affairs Specialist
- Compliance Officer
- Production Manager
- Process Engineer
- Validation Engineer
- Manufacturing Engineer
- Quality Systems Engineer
- Risk Management Specialist
- R&D Engineer
- Operations Director
- Pharmaceutical Manufacturing Manager
- Biotechnology Project Manager
- GMP (Good Manufacturing Practice) Auditor
Everybody Benefits from Watching This. Even Better When Done as a Group!
- Quality Assurance Manager
- Quality Control Supervisor
- Regulatory Affairs Specialist
- Compliance Officer
- Production Manager
- Process Engineer
- Validation Engineer
- Manufacturing Engineer
- Quality Systems Engineer
- Risk Management Specialist
- R&D Engineer
- Operations Director
- Pharmaceutical Manufacturing Manager
- Biotechnology Project Manager
- GMP (Good Manufacturing Practice) Auditor
Instructor Profile
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches…