Process Validation Training Course
This one-day course is regularly offered in Auckland, Adelaide, Brisbane, Hong Kong, Melbourne, Perth and Sydney. It is designed to provide an overview of the latest concepts and guidance documents for Process Validation as issued by the EU and PIC/S PE 009 Annex 15 in October 2015, as well as the US FDA in 2011. The course will provide practical insights into how “modern process validation” is carried out and how to avoid common and costly mistakes.
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 process validation approaches, and of course manufacture and deliver safe products.
What you will learn
Upon completion of this Process Validation Training Course participants will;
- Understand how to set a risk-based process validation strategy and build into your documentation validation efficiency
- Clearly understand the expectations and how to comply with the US FDA three-stage approach to Process Validation
- Clearly understand the expectations and how to comply with the PIC/S and EU approach to Process Validation, i.e. Annex 15 Qualification and Validation
- Understand the concepts of Continued Process Verification and Continuous Process Validation
- Understand how to establish and implement control strategies to maintain the validated state.
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.
The course is a combination of lecture-style learning and active workshops, with participants working in small groups on assigned tasks and case studies.
Who should attend?
- Quality Control personnel
- Operations or Manufacturing personnel
- Engineering personnel
- Validation Managers
- Validation Engineers
- Validation Specialists
AUD $450.00 + 10% GST
Prices are per person and include morning tea, lunch and afternoon tea (excluded for Virtual Training).
Register for a Process Validation Training Course below:
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.
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