This course is designed to foster a contemporary comprehension of process validation (PV), ensuring alignment with stringent regulatory expectations. Beyond a review of the objectives and standard practices, the program offers practical guidance on harnessing quality risk management principles. Attendees will learn how to strategically utilize these principles to formulate comprehensive validation plans that not only align with current regulatory standards but also establish a proactive approach to quality assurance. The course aims to empower participants with practical tools and insights to enhance their PV processes, promoting compliance and elevating the overall quality management framework.

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Content

Day 1

  • The Principles of Process Validation
    • The GMP reasons for process validation
    • Control of Variation, Process Capability Indices, and Sampling Considerations in process validation
    • The validation life cycle
    • Regulator’s current thinking
    • Ongoing changes in the Quality Management philosophy
    • Real-life examples
  • Process Design
    • Quality by Design, ICH Q8 and Q11
    • Quality Target Product Profile
    • Critical Quality Attribute
    • Critical Process Parameter
    • Design Space
    • Control Strategy
    • Continual Improvement
    • Link between QbD the Control Strategy and Process Design

Day 2

  • How to Manage the Data in Process Validation
    • Process understanding and effective process validation
    • Understand implications of validation deviations
    • Statistical Tools
    • Process Capability and Performance
    • Workshops exploring common PV problems and solutions
Participants

This course has been designed for validation professionals as well as those involved in approving process validation plans and projects. It also applies to anyone interested in the latest trends and methodologies in process validation that are rapidly becoming industry standards.

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 session with breaks.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions
 Sessions  Dates  Times
 Day 1  13 May 2024  8:45am join for 9am-5pm
 Day 2  14 May 2024  8:45am join for 9am-5pm

Times are based on Singapore time (SGT): UTC +8:00.

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

Fee
  • SGD $1400 (excluding tax) per participant
    • A 10% discount applies to 3 or more participants from the same company
Course Registration and Payment of Fee

To register, please contact Biju Kishor at biju.kishor@seerpharma.com.au 

Contact us for clarification or to discuss your interest in this course.

Refer to the Terms and Conditions