Process Validation Masterclass

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EVENT DATE

15th Jan 2018 to 16th Jan 201817th Jan 2018 to 18th Jan 2018

LOCATION

SingaporeKuala Lumpur Malaysia

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Overview

The Process Validation training course, to be delivered in Singapore as a 2 Day Masterclass provides with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation and information how to implement an effective validation programme.

Process validation is not a course, invented by regulators, pushed onto a company by QA staff. Process validation is a legal requirement in the pharmaceutical industry. Regulatory agencies will not approve your product without it. The concept of process validation is recognition that quality cannot be tested into the product.

In most cases, a branch within the “Quality” organisation of the firm handles coordinating and documenting compliance with this requirement, and the concept still evokes undertones of mystery and the unknown to some engineers and scientists from other disciplines within “Operations”. However, the fact is that operational personnel will most likely have to interact with the group responsible for the execution of the process validation efforts sooner or later. This course provides practical guidance on compliance with the requirements of process validation that leads to risk-based, reasonable and supportable informed decisions and planned activities. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.

Learning Objectives

With the new Draft Guidance for Industry “Process Validation:

General Principles and Practices”, the FDA requires a new direction. Validation is now a “Life Cycle

Process” with 3 stages:

 

  • Process Design
  • Process Qualification
  • Continued Process Verification

 

The focus is on process knowledge and process understanding. Both should be a result of development and verified in routine production. The “magic” 3 batches are not mentioned any more. What is very important nowadays is the term „scientific sound“, and explicit statistics are mentioned. Six Sigma elements (e.g. Design of Experiments,DoE) are also mentioned directly or indirectly.

There will be a new stage in routine production called continued process verification“.

 

Who should attend?

Directors, managers, personnel, technicians, and associates in the, Pharmaceutical, Medical Device, Biotechnology and allied industries with daily responsibilities in the areas process/product development and process validation including:

  • Quality Control
  • Quality Assurance involved in auditing validation protocols and reports
  • RA staff
  • Regulatory agency inspectors
  • Manufacturing personnel engaged in validation activities
  • Validation specialists from manufacturing, engineering, and maintenance departments
  • Research and Development, and software
  • Process Design and Development
  • Facilities
  • GMP/GLP Compliance
  • Change Control
  • Documentation
  • Training
  • Consultants

Topics Covered

 

Examples of Pharmaceutical Processes Subject to Process Validation

           

Active Ingredient Manufacturing Process Validation

Sterile Processes

Cleaning Validation

Drug Product Process Validation

Packaging Process Validation

Testing Processes

Shipping Studies

 

Why Perform Process Validation

 

            Legal Reasons

Technical Reasons

End of Process Development or Beginning of Manufacturing or Both

What Benefits Can Be Derived from Good Process Validation

Prospective versus Retrospective Validation

 

Validation Life Cycles

 

            Where Does Process Validation Fit

Validation Plans and Master Plans

Other Qualification Activities

Beginning with an End in Mind

Lessons from Project Management

 

Manufacturing Process Validation Planning – The Risk Analysis

Assembling the Prior Knowledge

Quality by Design and PAT

Anticipating Expectations

Process Mapping

Risk Analysis and Determining Validation Priorities

 

 

 

 

Failure Modes and Effects Analysis

FMEA: General Methods

FMEA: Specific process Examples from Drug Product, API, and Sterile

 

Design of Experiments for Manufacturing Processes

Defining the Problem

Forming Hypotheses

Identifying and Specifying Parameters and Attributes

Determining Criticality

Considering Potential Interactions

Defining the Sample Size

The Design Space

Specific Examples for Process Validation from Drug Product, API, and Sterile

 

Process Validation Planning – The Validation Protocol

Defining Key Milestones

Requirements Tracing

Prerequisites

Training

Qualifications

Sampling Plans

Methods

 

Executing Protocols

 

Anticipating Failure Modes in Execution

Communication Requirements

 

Post-Execution Activities

 

Handling Exceptions and Deviations

Investigations and CAPA

Writing Summary Reports

Presenting the Validation Product

Transition to the Life Cycle