Process Validation and Supplier Controls
for the Medical Device and Pharmaceutical Industries
Will be published approx. on 1. January 2030
Book
Hardback
978-1-4557-7883-6 (ISBN)
Description
Process Validation and Supplier Controls are hot-button issues for all stages of the design and manufacturing process, from the design and supply of polymers to product design and production. These procedures are especially critical in highly regulated sectors such as Medical Devices.
Vinny Sastri uses his extensive experience in the plastics and Medical Device industries to provide an accessible and practical guide to implementing Process Validation and Supplier Control regimes on both sides of the supply chain: materials design and supply, and product design and manufacture.
Best practice guidance is supported by a detailed explanation of the FDA and ISO regulatory frameworks for Process Validation and the Medical Device and Pharmaceuticals industries. Strp-by-step guidance is also provided regarding the validation process and related documentation.
The importance of design and development, risk management and the process validation life cycle are highlighted, and the good automated manufacturing process (GAMP) model is discussed. In addition, statistical methods and modeling are covered.
Sastri makes his content come to life by providing step-by-step instructions, flow charts and case studies from industry, along with templates and checklists that can be put to work straight away.
Vinny Sastri uses his extensive experience in the plastics and Medical Device industries to provide an accessible and practical guide to implementing Process Validation and Supplier Control regimes on both sides of the supply chain: materials design and supply, and product design and manufacture.
Best practice guidance is supported by a detailed explanation of the FDA and ISO regulatory frameworks for Process Validation and the Medical Device and Pharmaceuticals industries. Strp-by-step guidance is also provided regarding the validation process and related documentation.
The importance of design and development, risk management and the process validation life cycle are highlighted, and the good automated manufacturing process (GAMP) model is discussed. In addition, statistical methods and modeling are covered.
Sastri makes his content come to life by providing step-by-step instructions, flow charts and case studies from industry, along with templates and checklists that can be put to work straight away.
More details
Person
Author
President, Winovia, LLC, USA
Vinny Sastri, Ph.D., is the President of Winovia, LLC, a consultancy company specializing in quality management systems, notably in the area of medical devices. Dr. Sastri's areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CA/PA, and materials. He is a certified Six Sigma black-belt, and has a strong track record in leading, managing, establishing and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence. Dr. Sastri was on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training (along with the FDA) on the FDA Quality Systems Requirements and Industry Practice, Design Controls, Process Validation and Risk Management to the medical device industry. He now conducts public and in-house training through his company Winovia LLC. Prior to starting Winovia, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies including BASF, AlliedSignal and General Electric. He earned a Ph.D. from Rutgers University, completed post-doctoral work at Brooklyn Polytechnic Institute, and was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. Dr. Sastri has over 20 publications and 6 patents, and has presented at many international conferences and webinars in the United States, Europe, and Asia.
Vinny Sastri, Ph.D., is the President of Winovia, LLC, a consultancy company specializing in quality management systems, notably in the area of medical devices. Dr. Sastri's areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CA/PA, and materials. He is a certified Six Sigma black-belt, and has a strong track record in leading, managing, establishing and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence. Dr. Sastri was on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training (along with the FDA) on the FDA Quality Systems Requirements and Industry Practice, Design Controls, Process Validation and Risk Management to the medical device industry. He now conducts public and in-house training through his company Winovia LLC. Prior to starting Winovia, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies including BASF, AlliedSignal and General Electric. He earned a Ph.D. from Rutgers University, completed post-doctoral work at Brooklyn Polytechnic Institute, and was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. Dr. Sastri has over 20 publications and 6 patents, and has presented at many international conferences and webinars in the United States, Europe, and Asia.
Content
1. Introduction
2. Medical Device and Pharmaceutical Regulations, Standards and Guidance Documents
a. Medical Devices Regulations and Standards
i. US FDA CFR Parts 820
ii. ISO 13485:2003
iii. ISO 14971:2007
b. Pharmaceuticals Regulations and Standards
i. US FDA Parts 210 and 211
ii. ICH Q7, Q8, Q9 and Q10
c. US FDA and GHTF Guidance Documents on process validation
i. Guidelines on General Principles of Process Validation May1987 (FDA)
ii. Quality Management System - Process Validation Guidance GHTF/SG3/N99-10:2004 (Edition 2) January 2004
iii. Guidelines for the Industry - Process Validation: General Principles and Guidance January 2011
3. Process Validation Basics
4. Product and Process Design from Design and Development
a. Identification of Critical Product Parameters
b. Identification of Critical Process Parameters
c. Identification of Critical Raw Material Parameters
5. Risk Management and Process Validation
6. Process Validation Prerequisites
a. Procedures
b. Processes
c. People, Resources and Training
7. Use of statistical techniques in process validation
8. Installation Qualification
9. Operational Qualification
10. Performance Qualification
11. Process Validation and Good Manufacturing Practices (GMP) and Good Automated Manufacturing Process (GAMP)
12. Software Validation of Automated Instruments including 21 CFR Part 11 requirements
13. Process Controls
a. Process capability
b. Product Capability
14. Revalidation
15. Process Validation Life Cycle
16. The New Emphasis on Supplier Controls
a. Guidance Documents
b. Regulations and Purchasing Controls
17. Translation of Critical Raw Material Parameters to Purchasing Controls
18. Supplier and Material Qualification and Assessment
19. Supplier Identification, Selection and Controls
20. Documentation of Process Validation
21. Sample templates and forms
22. Bibliography
23. Glossary of terms
2. Medical Device and Pharmaceutical Regulations, Standards and Guidance Documents
a. Medical Devices Regulations and Standards
i. US FDA CFR Parts 820
ii. ISO 13485:2003
iii. ISO 14971:2007
b. Pharmaceuticals Regulations and Standards
i. US FDA Parts 210 and 211
ii. ICH Q7, Q8, Q9 and Q10
c. US FDA and GHTF Guidance Documents on process validation
i. Guidelines on General Principles of Process Validation May1987 (FDA)
ii. Quality Management System - Process Validation Guidance GHTF/SG3/N99-10:2004 (Edition 2) January 2004
iii. Guidelines for the Industry - Process Validation: General Principles and Guidance January 2011
3. Process Validation Basics
4. Product and Process Design from Design and Development
a. Identification of Critical Product Parameters
b. Identification of Critical Process Parameters
c. Identification of Critical Raw Material Parameters
5. Risk Management and Process Validation
6. Process Validation Prerequisites
a. Procedures
b. Processes
c. People, Resources and Training
7. Use of statistical techniques in process validation
8. Installation Qualification
9. Operational Qualification
10. Performance Qualification
11. Process Validation and Good Manufacturing Practices (GMP) and Good Automated Manufacturing Process (GAMP)
12. Software Validation of Automated Instruments including 21 CFR Part 11 requirements
13. Process Controls
a. Process capability
b. Product Capability
14. Revalidation
15. Process Validation Life Cycle
16. The New Emphasis on Supplier Controls
a. Guidance Documents
b. Regulations and Purchasing Controls
17. Translation of Critical Raw Material Parameters to Purchasing Controls
18. Supplier and Material Qualification and Assessment
19. Supplier Identification, Selection and Controls
20. Documentation of Process Validation
21. Sample templates and forms
22. Bibliography
23. Glossary of terms