Course Code: CPD/O/06/2021

CPD Hours: 14

Charged with the responsibility for validation, you will be confronted with a plethora of standards, guidelines, terms, and techniques. Understanding the language and the various validation methodologies (along with when and where to use them), is essential for success in this rapidly changing environment. There are many different paths you can take to achieve a validated state. Sometimes you get there by good luck, sometimes you make a few wrong turns. This course looks at the tools you need to navigate the various validation pathways you can take to make sure you get it right first time.

Asian GMP Operator on capsule blister packing line

Content

Day 1

Introduction to Validation Principles
  • Fundamental principles of validation
  • Regulatory requirements and guidance documents
  • Scope of validation
  • Sequence and stages of validation
  • Terms and definitions in validation
  • Use of Quality Risk Management in validation
Validation Planning
  • Validation Framework
  • How to approach validation
  • Validation master plans (VMP), project plans (VPP) and other documents
  • Applying QRM Principles to Validation
  • Critical and non-critical systems
  • Use of FMEA and HACCP for Validation Planning
  • Product/process rationales
  • Developing validation schedules – getting the work done
  • Regulatory observations/Industrial best practices

Day 2

Equipment Qualification
  • Requirement Specifications
  • GMP requirements for IQ, OQ, PQ
  • The new paradigm for equipment qualification
  • Protocol execution
  • Managing deficiency
Validation Planning
  • Change Control
  • Routine Re-validation Schedules
  • Periodic Review
Participants

This course has been designed for validation professionals as well as those involved in approving validation plans and projects. It also applies to anyone interested in GMP and the latest trends and methodologies in 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 sessions 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

Participants will attend both full-day sessions.

 Sessions  Dates  Times
 Day 1  26 June 2022  9:00am-5:00pm
 Day 2  27 June 2022  9:00am-5:00pm

Seats are limited: Only 25 participants per class

Fee and Registration
  • HKD $4800 per participant
    • A 10% discount applies for 3 or more participants from the same company

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

Refer to the Terms and Conditions

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Proposed Trainer

Shruti Narayana

Shruti has over 15 years of rich experience in quality management in the pharmaceutical industry with reputable companies in Southeast Asia and India and extensive experience in setting up and managing quality systems for manufacturing, packaging & distribution of pharmaceutical products assuring high quality standards as well as regulatory compliance. Shruti also has a comprehensive understanding of all aspects of quality management including manufacturing, validation, documentation, technology transfer, investigations, complaints, product recalls & returns, change control and product quality reviews as well as software packages like TMS quality compliance software, Blue Mountain calibration & maintenance software and QS Doc electronic documentation management system. Shruti can collaborate with management teams and contribute to the development of new products, engineering designs, manufacturing & training methods for continual improvements in quality & productivity. Shruti can communicate in Hindi.