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Overview
Do you need a practical understanding of process validation (PV) principles and expectations?

This 3-day course will define the requirements for preparation, planning and execution of Validation/Process Validation and how to maintain a state of control. It explores the 3 Stages of the validation product lifecycle, including Process Design, Equipment and Utility Qualification, establishing and implementing Process Performance Qualification or Process Validation requirements, and putting in place an Ongoing/Continued Process Verification program. The course is applicable to all sectors of the pharmaceutical industry - small and large molecules, innovators and generics. The content comprises a blend of presentation of concepts and details, followed by related practice application scenarios/exercises.

Presenters:
Bruce Davis, Principal, Global Consulting Ltd. is a professional engineer, and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and Quality Risk Management. He is an Associate to NSF Health Sciences, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering and facilitating application of Quality by Design. Bruce has been a member of ISPE since 1991 and held the position of Chair of ISPE International Board of Directors. He is active in supporting ISPE, including being a trainer for them. He led ISPE’s case study for practical implementation of Quality by Design (QbD) co-chaired the team for ISPE’s Technology Transfer Guide. Previous experience includes the position of past secretary to ASTM E55.03 Committee on General Pharmaceutical Standards and leading the team that set up a distance-learning course, for a UK university, involving some 40 webinars.

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.

Full Course Description:
This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes. It will help you link the science and risk-based process validation lifecycle approach to the Pharmaceutical Quality System. It will provide you with practical application of quality risk management in preparation for and planning for validation of manufacturing control strategy. Additional content will focus on technical approaches and pharmaceutical quality management processes supported by quality risk management applied to process design, qualification of equipment, and process performance.

With the implementation of ICH Q8, Q9, Q10 and Q11 guidelines, the draft ICH Q12, the US FDA Process Validation guidance, EMA’s Process Validation guideline and Annex 15, there is now a greater need to understand that process validation should be considered a science- and risk-based, life cycle activity rather than a one-time event of manufacture of three commercial scale batches. Companies should demonstrate that processes in the commercial phase of the lifecycle are maintained in a state of control using a science- and risk-based approach. A pharmaceutical quality system as discussed in ICH Q10 facilitates managing the product lifecycle and facilitates innovation and continual improvement using a change management system to support improvements in business efficiency.

Course content focuses on practical application of the lifecycle approach to PV. Application of Quality by Design principles (QbD) help with the Process Design phase of new products, drug substance processes, and legacy products and may yield significant business benefits by reducing operating costs and enabling more efficient manufacturing processes. This will be explained and exemplified. The Ongoing/Continued Process Verification stage can be considered a continuum from the end of process qualification stage until product discontinuation, i.e. FDA PV Stage 3.

Immediately apply the course learning objectives using the ISPE PQLI® Guide Series: Part 3, Change Management System as a Key Element of a Pharmaceutical Quality System and Part 4, Process Performance and Product Quality Monitoring System. Links to the Guides will be provided prior to the training course.

Course Modules:
Day 1

  • Regulatory Climate and Surrounding Changes in Process Validation
  • Breakout Scenario - Review of Warning Letters
  • Process Validation Basics US and EU
  • Breakout Scenario - Similarities and differences between US and EU
  • QRM Applied to PV
  • Breakout Scenario - FMEA
  • Developing Understanding of QbD to Develop Robust Control Strategies (PV Stage 1)
  • Breakout Scenario - Case Study
  • Wrap-up

Day 2

  • Equipment and Qualification
  • Breakout Scenario - Critical Aspects
  • Statistics for PV
  • Readiness for Process Performance Qualification (PPQ) / PV
  • Breakout Scenario - Design of PPQ / PV Study and Protocol
  • Acceptance Criteria, Number of Batches, Sampling Plan
  • Breakout Scenario - Acceptance Criteria Sampling Plan
  • Breakout Scenario - Selecting the Number of Batches for PV Stage 2
  • Wrap-up

Day 3

  • Process Validation / PPQ Execution
  • Breakout Scenario - Analyzing Data
  • Continued Process Verification (CPV) / Ongoing Process Verification (OPV)
  • Breakout Scenario - CPV and OPV Planning
  • CPV / OPV for Existing Products
  • Breakout Scenario - Comprehensive Case Study
  • Wrap-up

Take Back to Your Job:

  • Understand the importance of product and process understanding and patient requirements.
  • Know how to apply QRM tools for PV.
  • Recognize opportunities to leverage process design information to establish a process validation strategy and a process performance and product quality monitoring program.
  • Understand the challenges to the application of an entirely science- and risk-based approach.
  • Understand a variety of approaches to applying specific expectations of the lifecycle approach to PV including number of sampling, acceptance criteria and determining the number of batches for PPQ/PV.
  • Understand the differences in expectations among various major world markets.
  • Learn various approaches for deciding which attributes and parameters should be evaluated at a heightened level during PV stage 3.
  • Understand new expectations for routine process monitoring.
  • Understand the process validation lifecycle and the importance of maintaining an effective pharmaceutical quality system.
  • Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement.
  • Minimize chance of validation failures by learning about adequate preparation in process understanding and ancillary systems.
  • Acquire tools to prepare for a smooth validation execution.
  • Understand implications of validation deviations.
  • Maximize and be able to apply your understanding of ICH terminology including the principles of a science- and risk-based approach to the process validation lifecycle.
  • Recognize the value of the requirements of management’s responsibilities within the PQS.

Who should Attend?
This course is relevant to individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management. Specific job functions include: Development, manufacturing, engineering, quality, and validation professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those wishing to understand the concept of process validation as a lifecycle.


About ISPE:
ISPE is a not for profit, non-lobby industry association for healthcare industry professionals with in excess of 20,000 members world-wide. Our core purpose is to prepare these individuals to lead global change and innovation in manufacture or pharmaceuticals and other medicinal products. ISPE’s Australasian Affiliate membership is comprised of approximately 400 industry professionals from within its five chapters in New Zealand and Australia.

Cancellations:
ISPE reserve the right to change the date or speakers or program from that described. We also reserve the right in our absolute discretion and without further liability to cancel the program, in which case all event fees will be refunded. We do not provide refunds if you cancel as this enables us to keep our costs and prices to a minimum. We suggest you send a replacement.

Data Protection Act: The information on this form is subject to our normal rules of confidentiality and will be used only for the purposes it has been obtained for in accordance with the Data Protection Act 1998. This information will not be divulged to anyone outside ISPE without your express permission. By submitting this form, you are giving your consent to ISPE to hold the information. If you do not wish to receive related information from ISPE in the future please e-mail manager@ispe.org.au

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Organiser Information

Mandy Bromilow
ISPE
0447279008

ISPE Ask the organiser