Our host, Stacey Bruzzese interviews industry experts from pharma, biotech, med devices and laboratories.
Episodes
This week, Stacey presents the Validation Week awards ceremony. You'll find who won this years awards and what those recipients did to achieve their awards.
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 Rich Forsyth, Forsyth Pharmaceutical Consulting. Stacey and Rich discuss the lifecycle approach to cleaning validation, and the importance of creating cGMP approved cleaning programs that encompass the applications, methods and controls necessary for creation and launch of compliant cleaning programs that meet or exceed regulatory expectations.
Rich is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades. He has been involved with Cleaning Validation for over 20 years. Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.
Links:
FDA Cleaning Validation Guideline from CFR 211.67 -
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67
FDA CFR 211 -
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfmCFRPart=211
FDA Questions & Answers on Current Good Manufacturing Practices—Equipment -https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment
EMA Cleaning Guidance -
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
EMA Cleaning Validation Guideline on setting HBELs -
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
QnA on the implementation of the above guideline EMA - https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf
ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle-applications-methods-controls
WHO Cleaning Guidance -https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_in_cleaning_validation.pdf?ua=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.
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This week, Stacey is joined by Eric Kastango and Kevin Hansen to talk about compounding and specialty pharmacy, regulations, innovations and reputations. Compounding Pharmacists have a very challenging, and rewarding job, in their development of specialized medicines for individualized patient care. For many, there is satisfaction in working to solve the needs of patients through innovative partnership with the patient and their practitioner. Too often professionals in this space are mired by regulatory inconsistencies, special interest groups, lack of transparency and a tarnished reputation, all of which make this highly challenging job even more difficult. Today we will talk about some of the hurdles and opportunities in Compounding.
Eric Kastango, Expert Consultant and PharmacistEric has dedicated his life's work to patient safety through better sterile compounding, aseptic manufacturing, lean production, and robust quality management practices. He has practiced pharmacy in hospital, community, and homecare settings in a variety of roles. He was previously Corporate Vice President of Pharmacy Services for CoramHealthcare and also managed a cGMP outsource manufacturing operation for Baxter Healthcare. In addition to his consulting role, Eric continues to serve as a sterile compounding, 503B outsourcing, and patient safety subject matter expert for his clients, the American Society of Health-System Pharmacists, State Boards of Pharmacy, and was one of the key US Department of Justice expert witnesses during the New England Compounding Center trials from 2017-2019.
Kevin Hansen, PharmD, Assistant Director of PharmacyMoses H. Cone Memorial HospitalDr. Kevin Hansen is Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital in Greensboro, North Carolina and provides leadership and operational oversite for pharmaceutical compounding and pharmacy perioperative services. He is a preceptor for the Health-System Pharmacy Administration residency program. In addition, Dr. Hansen serves as adjunct faculty for The University of North Carolina Eshelman School of Pharmacy. Within the Moses H. Cone Memorial Hospital, as part of the Cone Health system, Dr. Hansen is involved in several committees and initiatives related to his practice interests of pharmaceutical compounding, handling hazardous drugs, medication and compounding safety, drug shortage management, and pharmacy perioperative services. He is a member of ASHP and the North Carolina Association of Pharmacists (NCAP). He currently serves a leading role through ASHP’sSterile Products Workgroup, as part of the Section of Pharmacy Practice Managers (SPPM).
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 Dr. Ross Caputo, President Eagle Analytical. Stacey and Dr. Caputo discuss contamination control. Contamination control is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. Any contamination that does occur must be thoroughly investigated, which often is time consuming, causing potential delays in production, and this is true for compounding pharmacies of all types.
Dr. Caputo has over 30 years of experience in the FDA-regulated pharmaceutical industry on sterilization research and aseptic processing focusing on process optimization and control. He has authored more than 50 publications and owns 15 patents, all related to infection control, sterilization processes and the production of sterile product. Throughout his career, Dr. Caputo has been an active participant and committee member of organizations such as AAMI/ISO and PDA, which are charged with the development of standards for the regulated marketplace. He has a PhD in Microbiological Physiology and Immunology from Miami University.
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 Dr. Kevin Hansen, PharmD Assistant Director of Pharmacy. Stacey and Dr. Hansen discuss how innovations in the RTA space are changing the way some hospital systems and their compounding pharmacies source these forms of drugs.
Dr. Hansen is Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital in Greensboro, North Carolina and provides leadership and operational oversite for pharmaceutical compounding and pharmacy perioperative services. He is a preceptor for the Health-System Pharmacy Administration residency program. In addition, Dr. Hansen serves as adjunct faculty for The University of North Carolina Eshelman School of Pharmacy. Within the Moses H. Cone Memorial Hospital, as part of the Cone Health system, Dr. Hansen is involved in several committees and initiatives related to his practice interests of pharmaceutical compounding, handling hazardous drugs, medication and compounding safety, drug shortage management, and pharmacy perioperative services. He is a member of ASHP and the North Carolina Association of Pharmacists (NCAP). He currently serves a leading role through ASHP’s Sterile Products Workgroup, as part of the Section of Pharmacy Practice Managers (SPPM).
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 is joined by Emma Ramnarine, Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. Stacey and Emma discuss managing high volume of PACs in a short timeframe and how to solve this problem.
Emma is Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. This initiative is sponsored by Chief Quality Officers of 20+ global pharma companies who have decided to speak with a unified voice, and develop standard solutions to reduce global PAC complexity. Emma has 20+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Risk Management, Quality Control and Quality Management Systems. She is currently on the PDA Board of Directors and has led several PDA Task Forces and Technical Reports (TR) including a series of TRs on “Implementation of Quality Risk Management” and “Risk Based Approach for Prevention and Management of Drug Shortages”. Emma is currently Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio. Prior to this, she was the Global Head of Analytical Science and Technology at Genentech/Roche, providing strategic direction and leadership for product control systems lifecycle management, analytical technology innovation and tech transfers. She is also a worldwide-recognized expert on Quality Risk Management (QRM), and continues to provide QRM training to regulatory authorities and at industry forums. Emma holds an M.S. in Pharmaceutical Sciences from the University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India. She is currently pursuing her PhD in Pharmaceutical Sciences from Technological University Dublin; her research focuses on this topic of transforming PAC management to solve the continual improvement and innovation challenge in the pharmaceutical industry.
Read more from Emma on this topic:
Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
Industry One-Voice-of Quality Concept Paper: Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transforms Post-Approval Change Management
Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence?
Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry
PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages
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 Raymond McKinney, Director NNIT. Stacey and Raymond talk about the perceptions and realities around cloud technology implementation for the life sciences industry.
Raymond McKinney Ray is a leading consulting, implementation and operations subject matter expert for IT operations in the pharmaceutical industry. He is responsible for delivery management and business development for IT services with an expertise in taking unstructured problems, performing process analyses, and constructing KPI-driven solutions to ensure measurement of achievement.
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 Lori Richter and Nuala Calnan to talk about risk management and quality management. This is the first episode in the QRM Corner series. We will cover some of the basics of Quality Risk Management in today’s episode and subsequently move on to “deep dives” focused on some of the more intricate and nuanced areas of Risk Management in future episodes.
• ICH Q9 Quality Risk Management Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management
• Annex 1 Manufacture of Sterile Medicinal Products: https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf
• WHO Risk Management Guidance: https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2TRS-981.pdf?ua=1
• European Medicines Agency Risk Management Guidance Format: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf
• European Medicines Agency Risk Management Plans: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans
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.
Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level.
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, 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.
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.
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.
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.
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.
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