Process Validation Lifecycle - Integration to the Pharmaceutical Quality System (T46) - New Course!

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Level: Intermediate
ISPE CEUs: 1.5
Type: Classroom Training Course
Primer Webinar Webinar Mouse

Date

Location

Country

Instructor(s)

21 - 22 May 2014 Brussels Belgium Ms. Line Lundsberg-Nielsen, PhD
21 - 22 May 2014 Indianapolis, IN USA Ms. Yanhui Hu, Ph.D.
2 - 4 Dec 2014 Tampa, FL USA Ms. Yanhui Hu, Ph.D.

Description

This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes, in establishing and implementing Process Performance, Product Quality Monitoring, and Change Management systems in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management. 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. Additional content will focus on technical approaches and pharmaceutical quality management processes supported by quality risk management applied to process design, qualification of equipment, utility and process performance.

With the implementation of ICH Q8, Q9, Q10 and Q11 guidelines and the USFDA Process Validation guidance and issue of EMA’s draft Process Validation guideline there is now a greater need to understand the science- and risk-based approach to management of the product lifecycle. For example, 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.

This course links the science- and risk-based process validation lifecycle approach to the Pharmaceutical Quality System. It provides practical application of quality risk management. Additional content will focus on technical approaches and pharmaceutical quality management processes supported by quality risk management applied to 3 phases of the product lifecycle:

  • Process Design
  • Equipment, Utility and Process Qualification
  • Continued Process Verification

This workshop-based course utilizes examples to support discussion for linking science- and risk-based process validation lifecycle approaches and the Pharmaceutical Quality System. Quality risk management is a key enabler: hence, principles, tools and techniques will be explained and practiced.

Course content focuses on two key pharmaceutical quality system elements:  change management throughout the lifecycle, and establishment and operation of a Process Performance and Product Quality Monitoring System in the continued process verification stage of the lifecycle. Application of Quality by Design principles (QbD) can help with the Process Design phase of new products, drug substance processes, and legacy products and yield significant business benefits by reducing operating costs and enabling more efficient manufacturing processes. This will be explained and exemplified.

The continued process verification stage could be considered a continuum from the end of process qualification stage until product discontinuation. For ease of representation this extended phase could be divided into an initial sub-stage (a) where sufficient data are being generated to produce variability estimates, and a subsequent sub-stage (b) of so called routine operation, where levels of sampling and monitoring may be reduced compared with earlier stages. The lifecycle can be described as follows:

Process Validation Lifecycle Flow Chart

PQLI Part 3 Cover Image

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.

ICH Q11

Mini-regulation handbooks for ICH Q8 (R2), Q9, Q10 and Q11 will be provided during the class.

Webinar 

We recommend participants complete the primer course webinar, Product Quality Lifecycle Implementation® (PQLI®) 101: Vision, Status and Next Steps that provides the background for the origins of the ICH guidelines, Q8 (R2), Q9, Q10 and Q11 and understand the link between these and other relevant regulatory guidelines and the ISPE PQLI Guides. You will receive information via email on how to access the webinar one week prior to the start of the training event.

Course Modules

Day 1

  1. Overview of Process Validation Lifecycle
    Breakout – Understanding the process validation lifecycle
  2. Quality Risk Management (QRM) & ICH Q9 tools (e.g. FMEA, risk ranking)
    Breakout - Learning about FMEA
  3. Pharmaceutical Quality System (Q10)
    Breakout – What are the key elements of a pharmaceutical quality system through the product lifecycle look like?
  4. Change Management throughout the lifecycle
    Breakout – Examples of change management in different phases of lifecycle
  5. Process Design
    Breakout – Process design deliverables

Day 2

  1. Review of Day 1
  2. Equipment and Utility Qualification – a science- and risk-based approach to equipment, utility and facility qualification (ASTM E2500 and ISPE’s two Guides on Commissioning & Qualification and Facilities, Systems & Equipment)
    Breakout – verification of ‘critical aspects’ and good engineering practices
  3. Process Performance Qualification
    Breakout – how to establish a process validation strategy and number of commercial batches to support process performance qualification
  4. Continued Process Verification
    Breakout – How to establish and implement a PP&PQMS for a product, including developing a monitoring plan
  5. Continual Improvement (CI) and the Process Validation Lifecycle
    Breakout – Product data analysis
  6. Management's role in the process validation lifecycle
  7. Learning you can take back to your company

Take Back to Your Job

Throughout the process validation lifecycle:

  • Understand the importance of product and process understanding and patient requirements.
  • Apply QRM tools.
  • 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 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.
  • Use risk assessment as part of Change Management to identify and implement continual improvement opportunities.
  • 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.

Note: This course will not cover formulation development, the regulatory submission processes or detailed engineering designs.

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 that are new to the concept of process validation as a lifecycle.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE API, C&Q, CU, OSD, PAT, PPD, and Sterile Communities of Practice (COPs).

Continuing Education Units  

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 25 February 2014

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