INSTALLATION, OPERATION AND PERFORMANCE CGMP REGUL 2016 - Life Cycle Process Validation According to FDA and other Standards - By Compliance Global Inc

Website https://complianceglobal.us/product/700474/MichaelLevin/Lifecycle-%20process-validation-%20according | Edit Freely

Category Education; E-Learning

Deadline: July 21, 2016 | Date: July 21, 2016

Venue/Country: online webinar, U.S.A

Updated: 2016-06-29 19:57:28 (GMT+9)

Call For Papers - CFP

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 : https://complianceglobal.us/product/700474/MichaelLevin/Lifecycle-%20process-validation-%20according-to-%20fda%20%E2%80%93and-%20other%20-standards/1

Email: supportcomplianceglobal.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.