Process Validation (PV) Workshop:
Life Cycle Management & Risk Based Approaches
Friday
12 May 2017
9am-5.30pm
NUSS Suntec City Guild House
3 Temasek Blvd, 401-402 Suntec City
The Course
There have been significant changes in the way regulators view management of product quality and validation throughout a product's lifecycle. These changes are predicated on the ICH guides Q8-Q11. In 2011, FDA introduced revised guidance for process validation (PV); requiring consideration to process performance and continued process verification. EU issued similar PV guidance and Annex 15 of the PIC/S guide has also been updated to incorporate similar "enhanced" approaches. The way in which validation and lifecycle management of pharmaceutical products will be viewed is undergoing a paradigm shift to incorporate science and risk-based principles.

This course will provide important information regarding the adoption of lifecycle validation practices by various regulatory authorities;  the context of these developments, how they impact companies and what the key actions will be for companies operating in Singapore or the wider Asia Pacific region.
ISPE Product Quality Lifecycle Implementation® (PQLI®) was formed specifically to address these issues and to provide industry with guidance for a practical approach to implementation of ICH requirements. Within PQLI, there is an active Process Validation focus group which has developed resources, industry training and presented conferences specifically on the subject of Process Validation.

The material presented will draw on the work by ISPE and provide insight into how regulators and industry are thinking about and approaching these changes in the US, EU and international markets and will include key principles such as:
  • ICH and other international regulatory guidance driving these changes
  • Regulatory trends and the current state of regulatory expectation for lifecycle validation
  • Evolution of quality and validation into all aspects of Product Realisation - the focus is no longer just about activities at manufacturing sites
  • Application of science and risk based thinking to pharmaceutical and biotech products
  • QbD principles and how these will impact existing operations - in practical terms ("how it impacts me")
  • What this means for new and existing or legacy products.
  • Expected approaches to process performance and continuous process monitoring
  • The role change management plays in this new paradigm.
  • A look into the future - what to expect on the horizon
There will also be discussion sessions and practical examples, to facilitate learning.

It is recommended that participants should be familiar with basic concepts of validation and quality risk management prior to attending this course.
Who should Attend?
  • Quality and validation practitioners, managers and operational staff who want to understand and utilise science and risk-based validation approaches.
  • Quality assurance, validation and technical professionals, management, service providers, and operations personnel involved in quality, validation and regulatory decision making.
Take back to your Job
  • Understanding of science and risk based thinking, the drivers behind changes in GMP requirements for this and expectations including emerging regulatory views in US and EU.
  • An overview of ISPE's PQLI initiative parts 1 to 4 covering development, CQAs, CPPs, control strategies and the case studies as well as the role of change management and the technical and scientific methodology for adopting a process performance and product quality monitoring system (PP&PQMS)
  • An update on current developments in Process Validation (including recent ISPE work and discussion papers in this area)
  • Relevance of these principles to ICH guidance on Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10)
  • Understanding of how this may impact your validation program; now and in the future
Programe Outline 
Session 1:
Science and risk based approaches to Product Realisation including Process Validation regulatory guidances, ISPE PQLI Practical Guides work and current trends in Process Validation

Session 2:
Product and Process Understanding and Quality Risk Management (ICH Q9 and FDA Process Validation Stage 1)

Session 3:
Process Validation Stage 2 - Facility/Equipment qualification and number of PPQ/PV batches.

Session 4:
Continued (Ongoing) Process Verification and monitoring, including implications on legacy products (Process Validation Stage 3)

Session 5:
Pharmaceutical Quality System - Process Performance and Product Quality Monitoring System (PPPQMS) & Change Management (ICH Q10)

Session 6:
Process Validation for CMOs and during Tech Transfer and looking to the future - what to expect.
Course Instructor
Maurice Parlane, Director, CBE Pty Ltd, and New Wayz Consulting Ltd. is a professional engineer with 29 years' experience in technical and consulting roles within the biopharmaceutical industry, including 19 years as an industry consultant.
His core skills and experience are in manufacturing and compliance management; process design and improvement; validation and operational excellence. Maurice has assisted numerous organisations to establish, improve or scale-up manufacturing operations in Australasia and the Asia Pacific region. Prior to this; he held senior engineering and manufacturing roles within the Glaxo group of companies.
He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is a past president and current director of the ISPE Australasian Affiliate, and is a member of ISPE Asia Pacific Regulatory and Compliance Committee and the PQLI Process Validation Committee. He is a chapter lead in the development of ISPE's Good Practice Guide for process validation
Registration Fees

Early Bird* /
Group Rate**
Regular
Member S$ 395 S$ 495
Non-member S$ 495 S$ 595

* Early Bird Rate valid for bookings before  30 Apr 2017
** Group Rate valid for bookings of  at least 3 persons . If a group comprises members & non-members, the respective group rate applies, according to membership
If you have any questions or need assistance with your registration, please contact Kristina Autenrieth at ispesingaffiliate@gmail.com
Thank you to our sponsors: