Process Validation Masterclass

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


SingaporeKuala Lumpur Malaysia

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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With the new Draft Guidance for Industry “Process Validation: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




Sampling Plans



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