Overview:
This webinar course covers a variety of topics on validation of pharmaceutical product and process according to FDA standards and others.
Why Should You Attend:
FDA Guidance on Process Validation: General Principles and Practices
Lifecycle and process validation
ICH Q10, FDA and EU – focus on validation
cGMP regulations and Process Validation Guidance
Data analysis and statistical tools for Process Quality Management (PQM)
Examples of statistical tools and ASTM standards
Process Verification vs. Process Validation
Areas Covered in this Webinar:
Qualification vs. validation vs. verification
Life Cycle approach to validation
Regulations for Process Validation: Review of FDA, GHTF, and GAMP Requirements
Documentation and testing: Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ)
Acceptance Criteria of equipment qualification Process Validation
Validation Protocol as per FDA standards
Learning Objectives:
To acquire an in-depth understanding of modern process and equipment validation techniques
Who Will Benefit:
Formulators
Process Engineers
Validation/Regulatory Compliance/ Quality Assurance Personnel
Production Managers who want to make sure that their equipment and processes are in compliance with validation requirements of various regulatory bodies and directives
For more information, please visit our website or contact us on:
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Michael Levin, Ph.D., has edited a very popular “Pharmaceutical Process Scale-Up” handbook (3rd edition published in 2011), and has contributed chapters on “Tablet Press Instrumentation” and “Wet Granulation: End-Point Determination and Scale-Up” in the Encyclopedia of Pharmaceutical Technology. He also wrote dozens of validation protocols executed for various computerized systems and unit operations.
This webinar course covers a variety of topics on validation of pharmaceutical product and process according to FDA standards and others.
Why Should You Attend:
FDA Guidance on Process Validation: General Principles and Practices
Lifecycle and process validation
ICH Q10, FDA and EU – focus on validation
cGMP regulations and Process Validation Guidance
Data analysis and statistical tools for Process Quality Management (PQM)
Examples of statistical tools and ASTM standards
Process Verification vs. Process Validation
Areas Covered in this Webinar:
Qualification vs. validation vs. verification
Life Cycle approach to validation
Regulations for Process Validation: Review of FDA, GHTF, and GAMP Requirements
Documentation and testing: Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ)
Acceptance Criteria of equipment qualification Process Validation
Validation Protocol as per FDA standards
Learning Objectives:
To acquire an in-depth understanding of modern process and equipment validation techniques
Who Will Benefit:
Formulators
Process Engineers
Validation/Regulatory Compliance/ Quality Assurance Personnel
Production Managers who want to make sure that their equipment and processes are in compliance with validation requirements of various regulatory bodies and directives
For more information, please visit our website or contact us on:
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Michael Levin, Ph.D., has edited a very popular “Pharmaceutical Process Scale-Up” handbook (3rd edition published in 2011), and has contributed chapters on “Tablet Press Instrumentation” and “Wet Granulation: End-Point Determination and Scale-Up” in the Encyclopedia of Pharmaceutical Technology. He also wrote dozens of validation protocols executed for various computerized systems and unit operations.
