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5308 Process Validation Requirements and Industry Practice
Instructors:
» -
Next course:
No scheduled date. Contact us for info.
Course Venue:
» -
Agenda:
Day 1: 8.00-17.00 Registration 07.30-08.00
Day 2: 8.00-17.00
Day 3: 8.00-12.00 + Lunch
Price:
€ 2.295 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
» -
Next course:
No scheduled date. Contact us for info.
Course Venue:
» -
Agenda:
Day 1: 8.00-17.00 Registration 07.30-08.00
Day 2: 8.00-17.00
Day 3: 8.00-12.00 + Lunch
Price:
€ 2.295 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
This course is arranged together with:
www.aami.org
(The Association for the Advancement of Medical Instrumentation)
Industry field:
Medical Device industry
Course description:
This 2½ day program provides regulatory affairs experts, quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System regulation while offering information on how to implement an effective validation program.
Objective
Upon completion of the course, participants will be able to apply the principles of process validation to their operations and know how to choose relevant statistical tools and techniques. Plus, participants will come away with an understanding of the process validation guidance issued by the Global Harmonization Task Force in 2004. In 2006, the U.S. Food and Drug Administration brought the course in-house to train Office of Compliance employees.
Format
This program provides intensive coverage of the elements of process validation. The highly interactive format includes a variety of situational analyses that provides you with the opportunity to apply new information to actual process validation scenarios. Industry "best practices" are presented to demonstrate examples for compliance strategies. In addition, participants will work through a series of case studies that illustrate the various aspects of a validation program.
Program At-A-Glance
Who should attend:
Instruction is targeted to professionals directly involved in meeting FDA's Quality System requirements such as those in regulatory affairs, quality assurance, process development, or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of the Quality System regulation, including direct work experience.
www.aami.org(The Association for the Advancement of Medical Instrumentation)
Industry field:
Medical Device industry
Course description:
This 2½ day program provides regulatory affairs experts, quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System regulation while offering information on how to implement an effective validation program.
Objective
Upon completion of the course, participants will be able to apply the principles of process validation to their operations and know how to choose relevant statistical tools and techniques. Plus, participants will come away with an understanding of the process validation guidance issued by the Global Harmonization Task Force in 2004. In 2006, the U.S. Food and Drug Administration brought the course in-house to train Office of Compliance employees.
Format
This program provides intensive coverage of the elements of process validation. The highly interactive format includes a variety of situational analyses that provides you with the opportunity to apply new information to actual process validation scenarios. Industry "best practices" are presented to demonstrate examples for compliance strategies. In addition, participants will work through a series of case studies that illustrate the various aspects of a validation program.
Program At-A-Glance
| Day 1 08.00-17.00 |
• Introduction and Overview to Process Validation • Quality System Regulatory Requirements for Process Validation • Elements of Process Validation • Process Validation and Design Control • Equipment Installation Qualification (IQ) |
| Day 2 08.00-17.00 |
• Process Operational Qualification (OQ) • Statistical Methods and Tools for Process Validation • Performance Qualification (PQ) • Software Validation • FDA Inspectional Approach |
| Day 3 8.00-12.00 |
• Process Monitoring, Control and Documentation • Retrospective Validation • Revalidation • Statistics for Setting Acceptance Criteria 12.00 Lunch (optionally) |
Who should attend:
Instruction is targeted to professionals directly involved in meeting FDA's Quality System requirements such as those in regulatory affairs, quality assurance, process development, or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of the Quality System regulation, including direct work experience.
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com