Course Description
This three-day Process and Software Validation training course is designed for professionals in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who are responsible for process and/or software validation.
Who Should Attend
This course is appropriate for individuals responsible for planning and operating a compliant validation program, including:
- Key players such as Process Engineers, Operations, Quality, and Regulatory personnel
- R&D, Design Engineers and Product Formulators who translate product requirements into manufacturing requirements
Learning Objectives
Through training, participants will learn:
- Process Validation from a regulatory perspective
- Process Validation Requirements and the Elements of a Process Validation Master Plan
- How to implement a Documented Validation System
- How to design and execute a Validation Protocol
- The Validation Life Cycle
- Software Validation
Course Outline
I. Introduction to Process Validation
- Regulatory Perspective
- Understand the importance of process validation from a compliance perspective
- Recognize the role process validation plays in understanding process and product variability
- Understand the perspectives of the FDA, international regulators and the GHTF
- Appreciate the consequences of non-compliance, a review of recent Warning Letters and Consent Decrees
- Process Validation Requirements
- Requirements of 21 CFR Part 810.75
- Requirements of ISO 13485:2003 and ISO 14971
- Recommendations of GHTF N99-10
- 21 CFR 211, ICH- Guidance
- Difference between validation, verification, qualification, commissioning
- Approaches to validation (i.e. prospective, concurrent and retrospective validation)
- Elements of Process Validation Master Plan
- Master Validation Plan
- Site Master Plan
- Assessing the status of existing systems
- Identifying the systems to be validated
- Assigning the priority and importance
- Defining and controlling the Master Validation Plan (MVP)
- An audit perspective of the Validation Master Plan
Group Exercise: “Create Validation Master Plan”
II. Process Validation System
- Implementing a Documented Validation System
- Documented Validation System
- Design, Installation, Operation and Performance qualifications
- Validation protocols and reports
- Application of risk management to process validation
- Training and competence
- Determining when revalidation is required
- Change Control
Group Exercise: Analysis of a Validation Protocol
Group Exercise: Write a Validation Standard Operating Procedure
III. Designing a Validation Protocol
- The Process Validation Steps
- Design Qualification
- Installation Qualification
- Operation Qualification
- Process Qualification
- Defining the protocol
- Executing the protocol
- Documenting the results of the validation
- Discrepancies during validation
- Protocol deviations and failures
- Validation Protocol Design
- Establishing the objective
- Defining the critical process parameters
- Defining tests to perform
- Defining acceptance criteria
- Deviation report & Log
- Use of the protocol as the report
- Role of measurement and analysis
- Installation Qualification
- Manuals
- Equipment life cycle
- Preventive maintenance
- Calibration
- Utilities
- Remedial maintenance / moves
- Requalification
Individual Exercise: Write an IQ Protocol
- Operation Qualification
- Operations Manuals
- Determining functions to test
- Programming vs. parameter entry
- Standards
- Recording observations
- Difference between OQ and Capability Studies, and purpose of each
Individual Exercise: Write an OQ Protocol
- Process Qualification / Process Validation
- Statistical Tools of Process Validation
- Averages, medians, mode and standard deviation
- Cpk or process capability
- Control charting to monitor performance
- T-tests, ANOVAs and F-tests
- Design of Experiments
- Data handling and data analysis
- Trials
- Determining Acceptance Criteria
- Classical Design Space
- Statistical Tools of Process Validation
Individual Exercise: Participants will develop test criteria for a Validation Protocol
IV. Executing a Validation Protocol
V. The Validation Life Cycle
- Re-validation
- When, why and what
- Handling problems during re-validation
- Product and process implications
- Product complaints and process failures
- Evaluating process parameters as a cause of product failures
- Design changes
- Process change history
- Role of corrective action and FMEA
- Amending the existing MVP
VI. Software Validation
- Software Validation
- Scope of implementation
- System control, roles and responsibilities
- Electronic records and electronic signatures
- System requirements through to validation
- Handling and assessing source code
- Role and importance of the traceability matrix
- Defining and executing test scripts
- System validation
- Software customization and changes/updates
VII. Closing
Prerequisites
Text
Course Format
24 hours
Available virtually
Course Instructor: Garrett D. Rathgeber Jr. Ph.D. – Consultant – Quality Management & Regulatory Compliance
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