This training course has been crafted to enhance your comprehension of the present criteria governing the design, execution, assessment, and reporting of equipment qualification and validation studies. Explore how adopting a science and risk-based approach to validation can not only drive business efficiency but also elevate reliability, fortify processes, and ensure product quality robustly. Embracing this methodology can significantly contribute tangible value to your business, simultaneously enhancing safeguards for patients. Gain insights into the latest industry standards and best practices to stay at the forefront of ensuring the efficacy and integrity of your processes.
Content
Day 1: Introduction to Validation Principles and Application of Quality Risk Management (QRM)
- Fundamental Principles of Validation and Qualification
- Explore regulatory requirements and the scope of Validation and Qualification (Q&V)
- Understand the sequence and stages involved in Q&V processes
- Validation Planning
- Regulatory requirements of Q&V
- Scope of Q&V
- Sequence and stages of Q&V
- Validation Planning
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- What is in a validation program?- Delve into the components of a validation program
- Validation master plans (VMP), project plans (VPP) and other documents
- Apply Quality Risk Management (QRM) principles to validation, emphasizing a science and risk-based approach
- Critical and non-critical systems Distinguish between critical and non-critical systems
- Utilize Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP) for validation planning
Day 2 Design, execution, assessment, and reporting of Equipment Qualification
- Equipment Qualification (The key components expected for effective equipment qualification)
- Identify key components crucial for effective equipment qualification
- Discuss User Requirement Specifications (URS) and the stages of Qualification, addressing GMP requirements for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Explore the new paradigm for equipment qualification and the application of risk management
- Cover protocol execution, evaluation, and reporting, along with managing deficiencies
- Maintaining a Validated State
- Understand change management strategies to effectively ensure patient safety and meet regulatory requirements
- Explore the validation lifecycle and continuous verification processes
- Discuss routine re-validation schedules and periodic review for sustained compliance and performance optimization
Participants
This course has been designed to provide personnel new to the Q&V principles and practices. It also applies to. It also applies to experienced GMP staff looking to update for compliance in the current Q&V requirements or practices.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 full day sessions with breaks.
PDF Certificates will be provided to participants electronically.
Contact us to discuss your interest in a public or private delivery of this course on-site or in a virtual-classroom.
