Product and Process Validation
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Introduction to Product and Process ValidationThe benefits of Validation
Definitions and terminology related to Validation
Determination of the need for Validation (versus Verification)Determining the need to Validate a Process
Examples of processes that should be Validated
Examples of processes that may be Verified
How do I know if a process cannot be fully Verified?
Integration of Risk assessment into Validation planningWhy use a Risk based approach to Validation
How to approach Risk Assessment
What are the various Risk Assessment Tools and Techniques
Performing a Validation Gap AnalysisThe purpose of performing a Validation gap analysis
How to plan and develop a gap analysis
Determining the methodology to use
Preparing for issues that may be found
Applying risk-based re-mediation
Implementing the Validation Programme (IQ, OQ, PQ)Implementing a Life Cycle Approach to Product and Process Validation
• Installation Qualification (I.Q.)
• Operation Qualification (O.Q.)
• Performance Qualification (P.Q.)
Creating and implementing the Validation Master Plan (VMP)The Validation Master Plan (VMP) development process
Why is a VMP necessary?
Who prepares and approves the plan?
How do you prepare and assemble a plan?
Elements of a Validation Master Plan
Implementation of the VMP
Documenting the closure
Requirements for effective and compliant Validation during the Design processQuality System Requirements for Design Controls
Rationale for Design Control Requirements
The Process of Design Control
Design and Development Planning
Design Input, Types, Sources
Design Output, Expectations
Implementing Design Reviews
Product and process Software ValidationGuidance for Software Validations
Categories of Software
The Software Life Cycle
User Requirements Specification
Software Design Specifications
Integration and Acceptance Test Specifications
Verifying Test Steps, Expected Outputs and Evaluation Criteria
Extent of Software Validation to be performed
Cleaning ValidationApproach to be applied when designing a Cleaning Validation program
Outline of regulatory expectations
The widely applied cleaning mechanisms
Relevant points to consider, residue detection, microbial & detergent considerations
Acceptance criteria, visual clean criteria, therapeutic dose based criteria, toxicological criteria, microbial criteria, 10 ppm criteria
Cleaning Process Sampling and Test MethodsSwabbing, Rinse Water, Coupon and Placebo methods of testing
Use of solvents
Microbial contamination considerations
Documentation Control and Management for ensuring Validation complianceDetermining the necessity for Documentation
Review of the various types of Documentation
Implementing and maintaining compliant Standard Operating Procedures
Understanding the fundamental documentation rules
Maintaining a controlled Documentation process
Regulation of Combination Products (US FDA)Examples of combination products. The FDA Combination Products Council. Applicable FDA regulations. Determining the regulatory approval process for Combination Products
Cleanroom Classification and ControlIs a “clean room” a regulatory requirement, what are the regulations? Classification of the clean room. Key environmental design aspects. Potential sources of contamination
Validating and Monitoring the CleanroomStandards to be considered when validating a Cleanroom. The widely applied validation tests to be performed. Ongoing performance monitoring tests
Equipment, Component, Material and Facility ValidationFixture Qualification
Component and Material qualification
Facility and Equipment Qualification
Implementation of a re-Validation programmeRe-validation and change control
Review and evaluation of Re-validation
Significance of “where appropriate” in Re-validation
Protocol ReportingQualification Report Content
Protocol Report summary
Data Analysis Summary
Implementation of the Audit programme to assure Validation effectivenessApproaches to Auditing a Validation Program
Developing the Audit terms of reference
Developing the Audit scope