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Voices In Validation
Voices In Validation episodes
- Risk Mitigation in SaaS Solutions w/Chris Wubbolt
Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing risk mitigation in SaaS Solutions.
- How SaaS works in GxP environments
- Can you use vendor supplied software for validation?
- Can we continue validation with ever changing software?
- Need to know, Compliant SaaS Provider Responsibilities
- Can cloud-based systems provide greater agility for companies?
- Risk factors still present in SaaS
- How to vet SaaS providers
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.
32 min - Virtual Auditing during Covid-19
Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, and John Patterson, Senior Consultant QACV Consulting, to the show. Today, Stacey, John and Chris will be discussing how to run a successful virtual audit during the Covid-19 pandemic.
- How to factor in audits into a changing schedule during a pandemic
- What goes into the decision to do a remote audit instead of on-site?
- What are the regulatory guidelines for virtual audits?
- What factors need to be considered when you do remote audits vs on-site?
- What needs to be performed before handling a remote audit?
- How can you overcome the limitations of a remote audit?
- How will the Covid-19 pandemic change the processes of audits moving forward?
- How can you have the best virtual audit experience?
John is a technology savvy leader, focused on improving human health through the compliant and secure enablement of new business technologies, particularly GxP, IT/digital systems. John is experienced in IT GxP Inspection readiness and Quality Management Systems (QMS) development, Cyber Security and Data Protection, Vendor Audit Planning, Preparation, Execution & Response, Standards Interpretation, Development & Governance, Data Privacy Enablement and Compliance, Strategy Development, Organizational Design & Governance, Records Management & E-Discovery Compliance, and Emerging IT/Digital Tech (e.g. Cloud, Mobile) Regulatory Surveillance & Advocacy.
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.
39 min - Managing data integrity in GCP environment
Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing how to manage data integrity expectations in GCP environment.
- Current guidelines that apply to Data Integrity
- What are the most important data integrity issues?
- The need for original documents for investigations
- What should SOP’s entail for firms to manage data risks?
- Specific regulations for eRecords and eSignatures
- Use of electronic documents for data integrity
- What have companies gone through during an audit of this type?
- Investigations Operations Manual 2020 - https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM607759.pdf
- Guide to Inspections of Pharmaceutical Quality Control Laboratories - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793
- Guidances and Manuals on Pharmaceutical Quality - https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality
- MHRA Guidance - Good clinical practice for clinical trials - https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials
- MHRA Inspection Toolkit - http://www.ct-toolkit.ac.uk/routemap/mhra-inspection/
- MHRA Inspectorate Computer System Validation – GCP - https://mhrainspectorate.blog.gov.uk/2017/04/20/computer-system-validation-gcp/
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1
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.
41 min - Implementing Quality Metrics for Validation w/Ivan Soto
On today’s episode, Stacey Bruzzese welcomes back Ivan Soto, Director Manufacturing Validation Emergent BioSolutions. Stacey and Ivan talk about the current challenges with the implementation of quality metrics for validation.
Stacey and Ivan discuss:
- What current challenges are companies facing when implementing new metrics?
- Which metrics have proved to be the most useful?
- FDA Guidance on Submission of Quality Metrics Data
- How quality metrics help us understand the lifecycle of equipment
- What do companies need to know when implementing metrics programs for validation?
- How can we account for supply chain elements?
- How will our current systems adapt to handle technological changes?
- What role will the FDA continue to play in oversight?
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.
30 min - Supply Chain Management in Times of Uncertainty
Stacey Bruzzese welcomes Dr. Siegfried Schmitt back to the show. Today, Stacey and Siegfried discuss how the supply chains have been interrupted and what we can do to solve these issues.
- Supply Chain has been disrupted by covid-19
- What exactly happens when supply chains have been changed?
- Is the drug supply being disrupted by covid-19?
- When could we see interruptions of drug supplies?
- Will our current efforts towards fighting covid-19 be enough to prevent breaks in the supply chain?
- Should we be concerned about the quality of medical products when non-medical companies are making medical equipment?
- Will this issue cause countries to re-evaluate medical imports?
- Will the supply chain model change forever?
- Where can companies find good references for how to evolve their current supply chain?
- Can companies streamline their process while maintain high quality?
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.
Find Siegfried’s Book “Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers,” published in two volumes at DHI Books, the PDA Bookstore and Amazon.com
DHI Books –Volume 1 - http://dhibooks.com/books/17353.html
Volume 2 http://dhibooks.com/books/17354.html,
PDA Bookstore –Volume 1 https://www.pda.org/bookstore/product-detail/5145-good-distribution-practice-volume-1
Volume 2 - https://www.pda.org/bookstore/product-detail/5148-good-distribution-practice-volume-2
Amazon –Volume 1 - https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911386/ref=sr_1_2?dchild=1&keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&qid=1585932902&sr=8-2
Volume 2 - https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911394/ref=sr_1_1?dchild=1&keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&qid=1585932902&sr=8-1
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.
34 min - COVID-19 and the Increased Demand for Personal Protective Equipment
Stacey Bruzzese welcomes former FDA investigator Alan Schwartz to talk about how medical device companies are handling the covid-19 pandemic.
This is the FDA enforcement policy that is discussed throughout the show. https://www.fda.gov/media/136449/download
Topics Include:
- How can we converse masks and respirators while demand is high?
- Will the influx of new masks and respirators be up to FDA standards?
- What is the FDA doing to halt counterfeit respirators?
- Will the quality of medical devices go down during this time?
- Is the US too late to effectively handle the demand?
- What are companies doing to conserve their products right now?
- How does this pandemic effect reliability testing?
- What will be the long term impact on medical device companies?
Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations. He has been Executive Vice President of mdi since 1994.
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.
36 min - Understanding Regulatory Guidelines with Igor Gorsky
Stacey Bruzzese welcomes Igor Gorsky to the show. Today, Stacey and Igor will be covering the essentials of regulatory guidelines and what goes into writing them.
- Why are the guidelines so important?
- What is the process for developing new guidelines?
- What is superior about the lifecycle approach?
- Why isn’t complying with Health Authority regulations enough to assure top quality?
- What would the industry do without Validation?
- What is a good business model to follow in this space?
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 variety of pharmaceutical facilities. Expertise in implementing Quality by Design in 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 their website at http://ivtnetwork.com.
54 min - Annex 1 - What the final draft reveals, and the impact to pharma.
Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Tim have a conversation about the European GMP annex 1 and what the final draft reveals.
- What annex 1 actually is?
- What are the biggest changes from the previous version to the current document?
- What are some of the broad reaching impacts that annex 1 will have?
- What was lacking in previous versions, regarding contamination control?
- The distinction of viable counts and non-viable particle counts in this draft cause for concern.
- How will pharmaceutical companies produce the correct data based on the new verbiage in this document?
- How could this document affect the current processes in the lab?
- How will environment monitoring be changed moving forward?
- Will there be too many new steps for labs to monitor their clean rooms?
- Will we see more relaxed views on post sterilization integrity testing?
- Does Tim see this latest revision as an improved to the most recent draft?
Dr. Sandle is the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited (a pharmaceutical organization). Dr. Sandle is a chartered biologist (Royal Society for Biology) and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University.
Dr. Sandle has over twenty-five years experience of designing and operating a range of microbiological tests (including sterility testing, endotoxin LAL methodlogy, microbial enumeration, environmental monitoring, particle counting, bioburden, isolators and water testing). In addition, Dr. Sandle is experienced in microbiological and quality batch review, microbiological investigation and policy development.Dr. Sandle is the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology website and forum (http://www.pharmamicroresources.com/). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.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.
45 min - Staying Compliant with Compliant Product Complaint Handling Systems w/Chris Wubbolt
On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about staying compliant with compliant product compliant handling systems.
Stacey and Chris talk about a variety of topics:
- Overview of the type of systems and the current requirements impacting them
- How does this integrate into an existing QRM system and does it need to be managed by a separate implementation and monitoring team?
- What exactly constitutes a “product complaint” under regulatory standards?
- What are the most common errors or omissions?
- Outdated systems, Lack of information, and Poorly defined procedures. How can an organization overcome these challenges?
- What are all of the QMS components?
- What are three steps they can take to ensure compatibility with existing QRM?
- What are the best practices for companies to start their QRM?
- How often should internal audits be done of the product complaint process?
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.
35 min - What is the benefit of contributing to industry publications? with Paul Pluta
Voices in Validation
Why is it important to contribute to industry publications?
On this episode, Stacey Bruzzese is joined by Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance. Stacey and Paul talk about the need for more contributors to industry publications, not only for industry growth but personal growth as well.
- Why role did IVT originally serve?
- How to network between industry personnel and consultants?
- The differences between JVT and GXP
- What are some of the most impactful topics covered in JVT and GXP?
- How does IVT stay relevant in an ever changing landscape?
- Why does contributing to IVT help personal growth?
IVT has been around for more than 20-years. As its name suggests the purpose of IVT has always been to provide learning, networking and industry growth opportunities for professionals in the validation and compliance space. Over the years many things within the industry have changed, but IVT continues to work to expand the knowledge base for those working in FDA Regulated industries. Today we are going to chat with Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance.
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.
29 min
About Voices In Validation
From the publisher's feed
Our host, Stacey Bruzzese interviews industry experts from pharma, biotech, med devices and laboratories.