Voices In Validation
Knowledge as an Asset in Pharmaceuticals

Knowledge as an Asset in Pharmaceuticals

September 22, 2020

This week, Stacey is joined by Marty Lipa, Executive Director Knowledge Management, Merck & Co. Stacey and Marty discuss the importance of “managing knowledge as an asset” in the pharmaceutical industry and learn how every company can begin to capitalize on this very important product.

1. Link to ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf

2. Link to find out more about the Knowledge Transfer Enhancement Framework (Chapter 6): https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1011&context=ditpress

3. Effective Knowledge Transfer During Biopharmaceutical Technology Transfer: https://www.ivtnetwork.com/article/effective-knowledge-transfer-during-biopharmaceutical-technology-transfer

4. Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers: https://www.ivtnetwork.com/article/managing-knowledge-and-risk-%E2%80%93-literature-review-interdependency-qrm-and-km-ich-q10-enablers

Marty has over 25 years’ industry experience and 12 years’ experience in Knowledge Management. He has published several industry specific works and is currently pursuing his Ph.D. at Technological University Dublin in Pharmaceutical and Regulatory Science with an emphasis on Knowledge Management. Lipa also leads the Knowledge Management Center of Excellence for the Manufacturing Division of Merck & Co., Inc.

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.

Science and Risk-Based Cleaning Validation. GMPs for the 21st Century.

Science and Risk-Based Cleaning Validation. GMPs for the 21st Century.

September 15, 2020

This week, Stacey is joined by Igor Gorsky, Senior Consultant Val Source Inc. Stacey and Igor discuss current restrictions and guidelines for cleaning, the shift to more science risk-based approach, streamlining the cleaning process while assuring patient safety and product quality.

Igor is an industry leader in Pharmaceutical and Biotechnology with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. He has a 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. Igor brings 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.

Computer Software Assurance and an Evolving Risk-Based Quality Approach

Computer Software Assurance and an Evolving Risk-Based Quality Approach

September 8, 2020

In this episode, Stacey hosts a panel discussion on computer software assurance. Stacey is joined by industry experts, Raechelle Raimondo, Ken Shitamoto, Pritam Khade, and Senthil Gurumoorthi, to talk about the upcoming guidelines from the FDA on computer software assurance, testing requirements, IT automation, risk, quality culture, and critical thinking mindset in the industry.

 

Raechelle Raimondo - Raechelle has more than 20 years of experience working for large/global corporations, small businesses and start-up companies. A proven history of implementing global systems utilizing a risk based systems lifecycle (SLC) approach and managing teams to support multiple projects, including forecasting and managing budgets. Strengths include leadership, portfolio/program management, delivering results, managing multiple priorities, effecting change, building teams, problem-solving, using interpersonal skills to build effective relationships, and understanding the link between technology & business needs to deliver compliant solutions that optimize processes & efficiencies.

 

Ken Shitamoto - Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.

 

Pritam Khade - Pritam is a Director of Global Quality Compliance at Allergan Inc.

 

Senthil Gurumoorthi – Senthil is a Director of IT Services at Gilead Sciences.

 

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.

WHO Data Integrity Draft Guidance

WHO Data Integrity Draft Guidance

September 1, 2020

In this episode, Stacey is joined by Felicia Ford-Rice, Senior Director Parexel International, the latest guidance from WHO about data integrity.

 

WHO Guideline: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_819_rev1_guideline_on_data_integrity.pdf?ua=1

 

Previous WHO Guideline: https://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf?ua=1

 

Felicia Ford-Rice leads a team of former FDA Reviewers and Investigators, and utilizes over 25 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice and Pharmacovigilance compliance. She provides consulting services on a variety of quality compliance topics including: Strategic GxP Compliance/ Inspection Readiness / Training / Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control / Corrective Action and Preventive Action /Product Complaint Assessments / Regulatory Action Remediation. She holds a Regulatory Affairs Certification, achieved a Master of Management in Business and a certificate in Project Management from Penn State University as well as a BS in Biology from Virginia Tech.

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.

Hands-Free Validation Using Augmented Reality and Artificial Intelligence

Hands-Free Validation Using Augmented Reality and Artificial Intelligence

August 25, 2020

In this episode, Stacey is joined by Steve Thompson, Director Industry Solutions, to talk about how digital technology is changing the life science industry. Stacey and Steve discuss paperless systems, remote validation, and eLogs.

Steve has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and is a regular speaker on industry trends and best practices. Steve received a Bachelor of Science, Computer Information Systems, degree in 1986.

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.

Life Science Industry Challenges, Opportunities and Next Steps – A Panel Discussion

Life Science Industry Challenges, Opportunities and Next Steps – A Panel Discussion

August 18, 2020

In this episode, Stacey is joined by Valarie King-Bailey, John E Lincoln, and Dr. Siegfried Schmitt for a panel discussion on Life Science Industry Challenges, Opportunities, and Next Steps.

 

Valarie King-Bailey – Valarie is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products and solutions. OnShore’s product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market. ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works. At QUMAS, an Irish-based software company, she served as Chief Marketing Officer where she was responsible for all global tactical and strategic marketing initiatives in addition to the development of their validation toolkit. Valarie founded OnShore Technology Group in 2004. OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008). She also received a nomination for Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from the University of Wisconsin – Madison (1982).

John E. Lincoln – John is principal consultant, J. E. Lincoln and Associates LLC, assists companies in the design and implementation of complete 21 CFR 111, 210, 211, 820 and ISO 13485 quality management systems, fully CGMP- compliant, and which have passed FDA audits. He compiles 510(k) submissions, new and changed, product Risk Management Files / Reports per ISO 14971, Design History Files, Technical Files, and Design Dossiers. He assists companies in remediation / FDA responses, SOP writing, audits, validations, including software. His work is described in peer-reviewed technical articles and workshops, worldwide. John has also managed pilot production, regulatory affairs, product development / design control projects. He has over 35 years of experience, 21 as a full time consultant, primarily with medical devices – working with start-ups to Fortune 100 companies. He is a graduate of UCLA.

Dr. Siegfried Schmitt - Siegfried 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, 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. Siegfried received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Dr. Schmitt is an active member of various industry associations, including DIA, PDA and ISPE, conference presenter and organizer of international events. He is also an accomplished author and editor, having won the coveted ‘distinguished PDA author / editor award’ in 2008 and 2012. Dr Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.

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.

The Importance of Scientific Communication in Pharmaceuticals

The Importance of Scientific Communication in Pharmaceuticals

August 11, 2020

In this episode, Stacey is joined by Bernard Hsu, Associate Director – Novartis Oncology. Stacey and Bernard discuss the process of communicating scientific data, including benefits, risks and outcomes, of prescription drugs is not only highly regulated, it can leave the audience confused and mis-informed if not done thoughtfully and with great care.

 

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.

 

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.

Robust Knowledge Management Activities in Process Validation to Ensure Intrinsic Compliance

Robust Knowledge Management Activities in Process Validation to Ensure Intrinsic Compliance

August 4, 2020

In this episode, Stacey and Cliff speak about new ways of thinking across the industry that aim to ensure appropriate, risk-based, least burdensome validation, with a focus of validation activities, instead of the traditional “are we compliant” mentality.

 

For more information on this topic:

ICH Q10 Feedforward, https://www.fda.gov/media/71553/download

  1. Process Validation Systems Based Inspection, https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf
  2. Operation Warp Speed, https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html
  3. Continuity Bill of Materials MBOM, https://www.cbsi-corp.com/wp-content/uploads/2012/02/NA50_03_Bill_of_Materials2.pdf

 

Cliff is a highly experienced consultant with a proven track record in efficient, agile and flexible compliance. His strengths include validation strategy, process mapping and gap analysis projects, both short and long term. He is exceptionally well regarded, and has worked collaboratively and co-authored with regulatory agencies, such as the FDA and HPRA, providing leadership training and advisory services. In addition to FDA, projects and workshops have been successfully completed for the following companies: Aveo, Amgen, Bayer, BioMarin, Celgene, Janssen, Kite, Lonza, Novartis, Parexel, Pfizer, Prolong. Cliff is also a long time contributor to the IVT Network, publishing articles in the Journal of Validation

Technology since 2010. Cliff was awarded the Kenneth G. Chapman Award in 2017 in recognition for his long standing efforts and contributions to validation.

 

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.

Adult Learning Theory and Its Impact on Corporate Learning Environments and Training Programs

Adult Learning Theory and Its Impact on Corporate Learning Environments and Training Programs

July 28, 2020

In this episode, Stacey is joined by Lori Richter and James Vesper. They talk about Adult Learning Theory and its impact on corporate training.

 

Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin.

 

Lori Richter’s Articles On The Topic:

Understanding Adult Learning Principles, CGMP Training Modalities ...

Applying Adult Learning Principles In CGMP Training

Building Effective CGMP Training Designed For The Adult Learner

 

James Vesper has worked in the pharmaceutical industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading the GMP training initiative. For 24 years, he was President of Learning Plus, a training consultancy and, in 2017, he joined ValSource as Director of Learning Services. Dr. Vesper has authored numerous books, book chapters, articles, and also speaks and teaches at international conferences and workshops, as well as consults for the World Health Organization (WHO). He received his PH.D. in education from Murdoch University, Perth, Australia.

 

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.

The Top 10 Questions You Should Be Asking Your Vendors: A Robust Assessment of Third-Party Suppliers

The Top 10 Questions You Should Be Asking Your Vendors: A Robust Assessment of Third-Party Suppliers

July 21, 2020

This week, Stacey is joined by Holly Baldwin, Quality Validation CSV, Sanofi Pasteur. Stacey and Holly discuss the most important questions when talking about security and data integrity when dealing with third-party suppliers.

 

Top 10 Questions:

 

  • Can I perform a vendor audit virtually or in-person?
  • What kind of intrusion detection system does SaaS vendor use?
  • Where is the primary and secondary (disaster recovery) data centers? Are either in a co-location site?
  • Where and when is Quality personnel in the validation process? Pre-approval, post-approval, change management?
  • How often does the SaaS vendor audit their offshore resources or third-party companies? What are the consequences if offshore company fails an audit?
  • Does SaaS vendor have documentation on their APIs (Application Programming Interface) , including any existing application assessment results and reports that demonstrate security best practices and audit results?
  • If your company, as Data Controller, needs to notify supervisory authority in 72 hours; what is the timeframe in which SaaS vendor will notify your company?
  • How will you be notified and how long before the implementation of the releases, upgrades and patches is the notification?
  • What is the SaaS vendor’s definition of an emergency change and when is Quality involved?
  • For an unplanned system outage, when will you be notified? How will you be notified? When will you have access to SaaS vendor’s Postmortem and/or CAPA created for unplanned outage?

Holly Baldwin has more than two decades in the Life Science Industry, primarily as a Computer System Validation/Quality authority and resource. She is also an expert in 21 CFR Part 11 Assessments, System Development Lifecycle documentation, audit preparedness and System Validation. Holly has been a speaker and trainer, sharing her expertise globally through organizations such as IVT,  ISPE, American Society of Quality, China Medical Device association and for the China  FDA now called the National Medical Products Administration.  

GDPR: https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/  and https://gdpr.eu/data-privacy/

 

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.

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