Process Validation Training Course
Course Category: Medical Devices
Course Title: Process Validation Training Course
An intensive one-day training course on how to establish and improve compliance with the GMP requirements for process validation. Both the FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485:2003 include requirements for process validation. In many cases manufacturers have not satisfactorily established compliance with the requirements in relation to process validation and have received adverse FDA inspections, including issuance of Warning Letters and Import Alerts. The course is designed to ensure delegates fully understand the essential business and regulatory requirements for process validation.
Course Presenter
This course is presented with our training partner, Tom Donnelly of Medicom Consulting.
Who should attend?
- Quality Managers
- Quality Control Professionals
- Healthcare Consultants
- Medical Device Consultants
- Enforcement Officers
- Regulatory Personnel
- Certification Bodies/Registrars
- Professionals in the Medical Device Industry & Supply Chain
Learning Objectives
- The regulatory requirements relating to process validation, and business benefits
- The key steps in performing adequate process validation
- Content of validation protocols.
- How to develop a validation master plan.
- Delegates should on completion of the course be able to identify, plan and execute process validation activities in a structured and efficient manner, to satisfactorily meet both business and regulatory responsibilities.
- Apply principles of the GHTF Guidance on process validation
- How FDA examine process validation during inspections
Course Structure
This course is a 8 hour/1 day course.
Course Start: 09:00a.m & Course Finish: 17:00p.m
A detailed course breakdown is as follows:
- US and EU regulatory requirements relating to process validation and guidance contained in the GHTF Process Validation Guidance.
- Development of a validation master plan
- Validation protocol content and development.
- Where software validation fits into process validation activities
Training Methodology
The course presents the Quality System Regulation comprehensively, it uses case studies, interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course. This course can also be tailored to meet your specific requirements.
What's Included on the course
- Comprehensive Course Manual
- Delivery by Expert (s) with real life experience
- Additional Handouts
- Training Certificate of Attendance
Further Information
Kelmac Group offer all of our Training Solutions on an In Company/In House basis. These solutions can be tailored to meet the specific needs and requirements of the client.
Our fees are very competitive and if you would like further information, please contact our office directly on +353 (61) 4491224 or email info@kelmacgroup.com
€1,095*/Person-
21 May 2012
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11 June 2012
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13 June 2012
