Voices In Validation

This week, Stacey welcomes back Ivan Soto, to discuss strategies that enable the implementation of a risk-based change management process. Utilizing a risk-based lifecycle approach to manufacturing allows us to identify, analyze, understand, manage and report any risk, or potential risk throughout the lifecycle. When it comes to change control, it can be much more challenging to apply risk-based methods.

Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and held several technical and management positions at different biotech and pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control, and Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical Catholic University of Puerto Rico.

Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions.

Resources:

https://www.ivtnetwork.com/article/streamlining-change-control-implementing-risk-based-change-management-process

https://www.fda.gov/media/85281/download

https://picscheme.org/docview/3817

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. 

This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance the ways in which they perceive and manage risk.

In this episode, our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging discussion on the ways in which bias and heuristics impact risk management, risk identification, and the decisions made during the process.

Resources from this episode:

1. ICHQ9 on Quality Risk Management

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.

This week, Stacey is joined by Igor Gorsky, author of Principles of Parenteral Solution Validation, A Practical Lifecycle Approach. Stacey and Igor discuss the history of Parenteral Process Validation and why the resources in this manual are so important in this day and age.

Resources from this episode:

Principles of Parenteral Solution Validation: A Lifecycle Practical Approach written by Igor Gorsky and Harold Baseman, published by Elsevier

Process Validation: General Principles and Practices - FDA

ICH guidance Q8 Pharmaceutical Development published May 2006

Q&A for the current working procedure for implementing the Q8, Q9, and. Q10 guidance's

Slides referenced by Igor

Igor is the principal consultant at Valsouce Inc. He also is a Pharmaceutical and Biotechnology Industries’ Leader with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. Proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10, and Q11 in a variety of pharmaceutical facilities. Expertise in implementing Quality by Design in the manufacturing environment throughout commercial product launch. Proven track record in building Validation organizations, establishing and implementing validation policies and training programs. Direct personal interface with FDA, MHRA, ANVISA, and other regulatory organizations.

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 the website at http://ivtnetwork.com.

This week, Stacey welcomes Justin Bechtel, Lead of Business Development for PharmAllies. Stacey and Justin discuss the future of technology in finding the Secret to Individualized Medicine with one part AI and one part 3D printing. Providing a more personalized medicine and drug delivery system is beginning to be a bigger part of what we do each day. Through the use of new technologies and with risk-based systems in mind, we can more accurately tailor products to provide the best response, highest integrity, and lowest risk, and AI is only one part of that effort.

Resources from this episode: http://www.ivtnetwork.com/sites/default/files/Artificial%20Intelligence%20Paired%20with%203-D%20Printing.pdf

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices

Justin Bechtel, Lead of Business Development

PharmAllies

Justin works as Lead of Business Development for a boutique consulting firm that specializes in Biopharma, Biotech, and medical device industries. His educational background includes both a degree in biology and a Doctorate in Physiotherapy with a focus in pediatrics and the spine. His passion is centered around providing a partner experience that includes both exceptional service and transparent communication. Justin works with a team that utilizes project management methods, Lean Six Sigma tools, and risk-based engineering in order to produce a product of excellence. His specialty is developing teams that deliver a successful project and program implementation to help clients streamline efficiency, increase productivity, and create risk-based compliant systems.

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.

For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast

This week, Stacey is joined by Dr. Ginette Collazo, CEO of Human Error Solutions. Stacey and Ginette provide some insight into the identification and reduction of human error in GMP facilities. In pharmaceutical manufacturing, upwards of 80% of process deviations can be attributed to human error. While regulatory agencies make clear that all deviations, including those caused by human error, must be fully investigated – can we say that we are effectively doing that as an industry?

About Our Guest:

Dr. Ginette M. Collazo is CEO of Human Error Solutions. She obtained her PhD. in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. She possesses over 10 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development, and Human Reliability fields. Ginette has worked for Bristol Myers Squibb, Johnson & Johnson, Schering Plough, and Wyeth. She has completed specialized studies in Human Reliability and has authored various publications on this topic. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn't when trying to change a culture from an error-tolerant environment to an error-free learning organization. Ginette has spoken about this topic in numerous professional conferences, including American Institute for Chemical Engineers, the Center for Chemical and Process Safety, the American Society for Quality, Interphex, and FDAnews.

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.

For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast

This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance the ways in which they perceive and manage risk.

This week our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging discussion on the ways in which bias and heuristics impact risk management, risk identification, and the decisions made during the process.

Resources from this Episode:

Understanding Problems of Subjectivity and Uncertainty in Quality Risk Management -https://www.ivtnetwork.com/article/understanding-problems-subjectivity-and-uncertainty-quality-risk-management

Risk Analysis and Ordinal Risk Rating Scales A Closer Look - https://www.ivtnetwork.com/article/risk-analysis-and-ordinal-risk-rating-scales%E2%80%94-closer-look

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.

For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast 

This week, Stacey welcomes back Bernard Hsu and Paul Pluta to talk about the curious case of death by black licorice. Unanticipated illness and even death due to unexpected effects of ingredients in the foods or medicine we consume occurs all too often. Sometimes these are deliberate, with people consuming more than prescribed or mixing medications. The IVT Network recently published a blog post Unexpected Toxicity From Drug Products on this very topic. Today we will discuss this case and many more as we discover the associated science with two of the authors. Bernard Hsu and Paul Pluta.

For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast

Resources for this episode:

Unexpected Toxicity from Drug Products: https://www.ivtnetwork.com/article/unexpected-toxicity-drug-products

A Man Ate 2 Pounds, Licorice Candy. This Is What Happened To His Organs: https://youtu.be/qg76qIZ4BQ8

A Boy Ate 150 Gummy Vitamins For Breakfast. This Is What Happened To His Bones: https://youtu.be/mZ6nREONy_4

A Boy Ate 25 Laxative Brownies In 1 Hour. This Is What Happened To His Kidneys: https://youtu.be/TMy0vJfKvzI

A Man Ate 100 Zinc Vitamin C Gummies Every Day. This Is What Happened To His Spinal Cord: https://youtu.be/oeyt2zVqCG8

A Woman Drank 1 Liter Soy Sauce Colon Cleanse In 2 Hours. This Is What Happened To Her Brain: https://youtu.be/QiBpKuTrFrw

A TikToker Drank 1 Liter Cough Syrup. This Is What Happened To His Brain: https://youtu.be/QKIobyk6Isc

A Mom Drank 3 Gallons Water In 2 Hours. This is What Happened to Her Brain: https://youtu.be/J3HivpHP-5I

A TikToker Drank 1 Bottle Nutmeg Spice. This is What Happened to His Brain: https://youtu.be/Gl3H23g5kT0

A Grandma Ate Cookie Dough For Lunch Every Week. This Is What Happened To Her Bones: https://youtu.be/Cwa8PdtWapE

Bernard Hsu, PharmD, Associate Director, Novartis Oncology. Bernard has a decade of experience in pharmaceutical product development at major pharmaceutical companies spanning all phases of development. Earlier in his career, his clinical training was in emergency medicine and toxicology. He is now Associate Director in Oncology Medical at Novartis. Most of Bernard's work today is in medical and scientific communications, both within the industry and to the general public.

Paul Pluta, Ph.D., Editor-in-Chief, IVT Journals. Paul has extensive pharmaceutical industry and university academic teaching experience, with many years managing validation in the industry. He has written chapters and edited books on cleaning validation and has published more than 100 papers and given numerous presentations. Pail has been involved with the Journal of Validation Technology and Journal of GXP Compliance as a writer and editor-in-chief for more than 10 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.

This week, Stacey is joined by Roberta Goode to talk about patient safety and how medical packaging is a key component of that. Stacey and Roberta discuss the nuts & bolts around “Selecting medical device packaging materials and sterilization methods to achieve appropriate sterility assurance levels and sterile barrier integrity throughout the labeled shelf life.”

Resources from this episode:

ISO 14971:2019 Medical devices – Application of risk management to medical devices - https://www.iso.org/standard/72704.html

ISO 24971:2020 Medical devices – Guidance on the application of ISO 14971 - https://www.iso.org/standard/74437.html

ISO 11607:2019 Packaging for terminally sterilized medical devices - https://www.iso.org/standard/70799.html

ISO 13485:2016 Quality Management System for medical devices - https://www.iso.org/standard/59752.html

21 CFR 820 Quality System Regulation - https://www.govinfo.gov/app/details/CFR-2011-title21-vol8/CFR-2011-title21-vol8-part820

ASTM D4169 -16: Standard Practice for Performance Testing of Shipping Containers and System - https://www.astm.org/DATABASE.CART/HISTORICAL/D4169-09.htm

ISTA 2a: Partial Simulation Performance Tests - https://ista.org/test_procedures.php

Roberta Goode, Principal, Altrec

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.

Today Stacey Bruzzese is joined by guest Rick Rhoads to discuss lessons learned in performing stability tests.

Traditionally, compounding pharmacists have relied on professional experience and published data to determine product stability. Based on this knowledge, compounders have extended beyond use dates when deemed safe and effective. With rapidly changing guidelines, these kinds of judgement calls are no longer allowable. Many compounders are forced to conduct expensive and time consuming stability studies to extend the BUDs for compounded sterile preparations.

• Article: Lessons Learned from a Trimix Stability Study in 503A Compounding Pharmacy by Rick Rhoads, PharmD.

• USP Stakeholder Engagement Plan for Beyond Use Dates (795) (797) • USP Review Perspective on Pharmaceutical Quality

• Historical: Beyond use date (BUD) refers to the date or time after which a compounded sterile/non-sterile preparation

• May not be stored and based on the original date of compounding. BUDs help decrease the risks to patients cause by physical or chemical degradation, microbial contamination and proliferation, and impact on the integrity of the product and it’s container. Compounding Pharmacist are faced with several challenges surrounding BUDs including, varying regulations from state to state, lack of stability testing on compounded preparation, lack of prior knowledge or experience with either the components of a compound, or the compounded preparation and many instabilities cannot be detected without the use of analytic equipment.

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. 

This week our series coordinators, Lori and Nuala, will engage their guest Valerie Mulholland in a lively discussion on a critical aspect of Risk Management, namely the skills and confidence necessary to making effective and timely risk-based decisions.

Articles:

1. Quality Risk Management: Seeking the Diamonds: Making the Case for Improved Formality in QRM Decision-making https://arrow.tudublin.ie/level3/

2. Role of Senior Leadership in Quality Risk Management | IVT - Risk - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management

3. Understanding the Concept of Formality In Quality Risk Management http://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management-0

Other Resources:

1. ISO 31010 – Risk Management - https://www.iso.org/iso-31000-risk-management.html

2. ICH Q9. Risk Based Decisions We first encounter it in the Introduction to the guideline: “Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.” And specifically, “…some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.”

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.