Process Validation Training Courses | Overview of US FDA | EU PIC/S | GMP | Validation Training
This one-day Process Validation training course is designed to provide an overview of the latest concepts and guidance documents for Process Validation as issued by the FDA in 2011 and the EU, PIC/S Annex 15 in October 2015 and to provide practical insights into how “modern validation” is carried out and avoid common and costly mistakes.
US, FDA and EMA differences in Process Validation
The US FDA and EMA have different approaches to Process Validation. Understanding these approaches will provide your team with the best opportunity to develop and implement your own compliant validation approaches, and of course manufacture or deliver safe products meeting GMP and related requirements.
Course Duration & Location
One-day, on your site or at an offsite location.
PharmOut’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.
PRICE: Process Validation Training Courses and Costs
Pricing per course is A$400 per person or A$4,000 per day plus GST for up to 15 participants.
This does not include travel costs.
*Smart device and WiFi may be needed for attendees for certain courses. If so, this will be designated in your registration confirmation materials.
Contact us for a quote if you need more that 10 trainees to be trained.
What you will learn
Upon completion of this Process Validation training course participants will;
- Understand how to set a risk based validation strategy and build into your documentation validation efficiency
- Clearly understand the expectations and how to comply with the US FDA’s three stages of Process Validation
- Clearly understand the expectations and how to comply with the PIC/S and EU’s approach to Validation, i.e. Annex 15
- Understand the concepts of continued process verification and continuous process validation
- Understand how to establish and implement control strategies to maintain the validated state
Course materials and Slides for Process Validation Training
Participants will receive a copy of the presentation(s), relevant notes and workshop materials.
A certificate of completion will be issued to participants who successfully complete the assessment.
A written assessment is conducted at the end of the course.
Process Validation Training | Course Format
The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.
Who should attend?
- Quality Control personnel
- Operations or Manufacturing personnel
- Engineering personnel
- Validation Managers
- Validation Engineers
- Validation Specialists
If you would like a quote or would need to ask questions, please contact us.
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If you need any assistance, would like a quote for personalised group training, or just have a general training question don’t hesitate to contact us.