Course Code: CPD/O/04/2021

CPD Hours: 14

The FDA's Industry Guidance document "Validation of Cleaning Processes (7/93)" stood alone for virtually 20 years. Since then and particularly in the period 2016-2020, we have seen significantly more guidance being published from key industry bodies including the EMA, PIC/S, PDA, ISPE, and WHO. But what do all these documents mean for you and your company?

This training course will help you understand the current 'cleaning validation landscape' by discussing the recent changes in regulatory expectations and what they mean for manufacturers. You will also gain insights into the modern application of a science- and risk-based approach to cleaning validation and be able to develop GMP-compliant cleaning validation (CV) protocols.

Asian GMP Operator inspecting pharmaceutical equipment

Content
Day 1: The Principles of Cleaning Validation
  • Regulatory basis / GMP reasons for cleaning validation.
  • Strategies for cleaning validation that complies with GMP
  • Practical limits for cleaning residues and exercises to practice the formulas
  • Health based exposure limits
  • Essentials of a cleaning validation protocol
  • Current industry practices
  • FAQs and case studies based on regulatory observations
  • New EU requirements for Health Based Exposure Limits (HBELs)
Day 2: The Practices
  • Workshops exploring common CV problems and solutions
Participants

You will benefit from this training if you are in a position of Quality or Validation Management or directly responsible for preparing and executing cleaning validation studies within a GMP facility.

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  05 May 2022  9:00am-5:00pm
 Day 2  06 May 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.

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Proposed Trainer

Gloria Pang

Gloria has over 26 years of experience in the GMP-regulated pharmaceutical and medical device industry. Gloria has managed various quality systems elements of organisations and was responsible for sustaining them to the required standards, including PIC/S, USFDA, EU, ISO, and ICH. Her principles areas of expertise include Quality Systems, Laboratory Control, Product Conformance Initiatives, Quality Assurance and GMP Upgrade Strategies, and validation. In addition, she has conducted numerous 3rd-party audits and gap analysis and provided remediation strategies in facilities intended for the manufacturing of APIs, final dosage forms, and medical devices. Besides establishing compliance, she has developed ISO/GMP/GDP training programs and delivered courses for organisations across the Asia Pacific region. Gloria can communicate in Mandarin.