Manufacturing Process Validation Training

Manufacturing process validation is a systematic approach used in the manufacturing industry to ensure that a process consistently produces products that meet predefined quality standards and specifications. It involves establishing documented evidence that the manufacturing process is capable of consistently producing products that meet predetermined requirements and quality attributes.

The validation process typically includes three stages:

1. Process Design: This stage involves defining the manufacturing process, identifying critical process parameters (CPPs), and establishing process control strategies to ensure product quality.

2. Process Qualification: During this stage, the manufacturing process is thoroughly evaluated and tested to ensure that it consistently produces products that meet predefined quality standards. This may involve conducting qualification studies, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

3. Continued Process Verification: Once the manufacturing process is validated, ongoing monitoring and verification are performed to ensure that the process remains in a state of control. This includes monitoring process performance, analyzing data, and implementing corrective actions as needed to maintain product quality and compliance with regulatory requirements.

Morning Session: Introduction to Manufacturing Process Validation

• Definition and importance of process validation in manufacturing

• Regulatory requirements and guidelines (e.g., FDA, ISO)

• Objectives and benefits of process validation

• Understanding Manufacturing Processes

• Overview of various manufacturing processes (e.g., injection molding, machining, assembly)

• Identifying critical process parameters (CPPs) and critical quality attributes (CQAs)

• Establishing process control strategies

• Types of Process Validation

• Prospective, concurrent, and retrospective validation

• Revalidation and periodic review of validated processes

• Differences between process validation and process verification

• Documentation and Data Collection

• Documentation requirements for process validation

• Data collection methods and tools

• Establishing traceability and accountability in data management

Afternoon Session: Risk Assessment and Mitigation

• Conducting risk assessments for manufacturing processes

• Identifying potential failure modes and associated risks

• Implementing risk mitigation measures

• Process Performance Qualification (PPQ)

• Planning and executing PPQ studies

• Determining sample size and acceptance criteria

• Analyzing PPQ data and interpreting results

• Continued Process Verification (CPV)

• Implementing CPV as part of ongoing process monitoring

• Establishing control limits and monitoring parameters

• Responding to deviations and out-of-specification results

• Case Studies and Best Practices

• Real-world examples of successful process validation initiatives

• Lessons learned and best practices for effective process validation

• Q&A session and open discussion

Prerequisites:  Manufacturing engineers, quality assurance professionals, production managers, and regulatory affairs personnel should attend this training

Who Should Attend: Any one from Industry?

Certification Exam: 1. each certification candidate is required to pass a written examination through online mode that consists of multiple choice questions

2. Passing marks is 60% and for Hard copy of certificate needs to pay Rs. 100 additional