Voices In Validation

Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of designing for manufacturability.

• Roberta details the 8 essentials of DFM

DFMA References

Assembly Automation and Product Design

G. Boothroyd, Marcell Dekker, Inc. 1992

Product Design for Manufacture and Assembly

G. Boothroyd and P. Dewhurst, G. Boothroyd Dewhurst, Inc. 1989

Marcell Dekker, Inc.  1994

Design and Analysis of Manufacturing Systems

Prof. Rajan Suri University of Wisconsin  1995

Product Design for Assembly: The Methodology Applied

G. Lewis and H. Connelly

Simultaneous Engineering Study of Phase II Injector Assembly Line

Giddings & Lewis  1997

Design for Manufacturing Society of Manufacturing Engineers,

(VIDEO)

Introduction to Design for (Cost Effective) Assembly and Manufacturing David

Steinstra, Rose-Hulman, 2015

IVT’s Medical Device Handbook: http://www.ivtnetwork.com/article/medical-device-validation-handbook

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.   

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On this episode, Stacey Bruzzese is joined by Karen Ginsbury, President & CEO of PCI Pharmaceutical Consulting Israel. Stacey and Karen talk about what’s new with global systems and regulatory guidelines.

 What’s new in Quality Management System

• For Virtual companies, what are their responsibilities in terms of quality systems?

More information on the topics discussed can be found at:

ISO 18091:2019

Quality management systems — Guidelines for the application of ISO 9001 in local government

     https://www.iso.org/standard/72808.html

Validation Week 2020

       http://www.cbinet.com/conference/pi20083

FDA Information on PQS

      https://www.fda.gov/media/92818/download

ICH Q10 Quality Management

      https://www.fda.gov/media/71553/download

IT and Computerized Systems Conference

     http://www.cbinet.com/conference/pi20045

ICH guideline Q10 on pharmaceutical quality system

 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf

ICH guideline Q9 on quality risk management

     http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf

Karen has over twenty years of experience in the pharmaceutical industry. ... After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On this episode, Stacey Bruzzese welcomes back Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL.  They discuss change management and the variety of factors that contribute to successful implementation.

• What is included in a solid change management SOP?

Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Stacey Bruzzese welcomes Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about a wide variety of change control topics.

• Alan gives a brief review of the product lifecycle

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL.  They discuss how to avoid blind spots when it comes to data integrity.

• What systems and processes need to be included in my Data Integrity program?

Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com

On today’s episode, Stacey Bruzzese welcomes Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions. They discuss a variety of aspects around the topic of data integrity.

• Why are we hearing more about audits and audit reviews lately?

Ivan has been in the life science industry for over 20 years and held several technical and management positions at different Pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com

On today’s episode, Stacey Bruzzese presents a recording with clips from a mock audit. The mock audit was recorded at a recent IVT conference and was facilitated by Alyce Deegan, Vice President of Data Integrity at Compliance Path LLC.

• What factors impede a zero-findings review?

These questions and more are covered during the mock audit. This episode has a lot of useful tips for anyone preparing for an audit. For additional information about Alyce’s presentation got to http://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk

Alyce Deegan has over 20 years of experience in Pharmaceutical, Medical Device and Gene Therapy industries.  Most recently, Alyce was the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA.  Throughout Alyce’s career she has held leadership positions in Quality, Validation and IT at companies such as Pfizer, Biogen and ThermoFisher.  Throughout her career she has built and continues to build "Unified Compliance Models" within companies to address the ever changing regulations and has been directly involved with multiple agency inspections throughout the years.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey back to talk about testing automation and how new technologies impact Computer Systems Validation (CSV).

Stacey and Valarie cover a variety of topics:

• With Parma moving toward AI, IoT, Big Data and more, what are some of the trends specific to Computer Systems Validation?

Valarie King-Bailey, is CEO of OnShore Technology Group –a Chicago-based global IV&V firm. Valarie has over 30 years of validation experience in the engineering and life sciences disciplines. She has conducted validation exercises for leading life sciences companies across the globe. She holds a B.S. in Civil & Environmental Engineering from the University of Wisconsin -Madison and an MBA in Information Systems from Keller Graduate School of Management. She received a lifetime achievement award from the University of Wisconsin College of Engineering and is a UW College of Engineering Distinguished Alumni.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about validation of manufacturing equipment, processes and computer systems – both hardware and software.

Stacey and Chris talk about a variety of topics:

• Chris gives a brief overview of CSV and why it’s important to the integrity of the product

Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the final part of our 3-part series.  Stacey and Roberta review the steps necessary for a successful product launch.

Stacey and Roberta cover a variety of topics:

• Roberta outlines the steps associated with the final phase prior to product launch

The following links have useful companion information for this episode:

Post-Market Requirements:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices

IVT’s Medical Device Validation Handbook:

http://www.ivtnetwork.com/article/medical-device-validation-handbook

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.   

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.