Voices In Validation

This week, Stacey is joined by Emma Ramnarine to continue their series discussing One-Voice-of-Quality. This discussion focuses in on the details for a greater understanding around the how’s and who’s that are necessary to this One-Voice-of-Quality vision.

Emma has over 15 years of experience in the pharmaceutical, biotechnology and medical device industry in the area of Quality System with focus on developing and leading Quality Risk Management (QRM), validation, and change control. She is a worldwide-recognized expert on QRM, providing QRM leadership, governance, guidance, and training to regulatory authorities and at industry forums. Emma has been an active member of the Parenteral Drug Association (PDA) for 13 years. She most recently led PDA”s Task Force for Technical Report No. 68 on “Risk Based Approach for Prevention and Management of Drug Shortages” and is also a member for PDA on the inter-association European Drug Shortages Team that was formed under EMA”s direction. She also led the Task Forces for PCMOSM Technical Report Series No. 54 on “Implementation of Quality Risk Management”. Emma joined the PDA Board of Directors as of Jan 2015, has been on PDA”s Regulatory Affairs and Quality Advisory Board (RAQAB) since 2013, and also co-leads PDA”s QRM Interest Group. Emma holds an M.S. in Pharmaceutical Sciences from University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India.

Read more from Emma on this topic:

1. 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

2. 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

3. Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence?

4. Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.

5. PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry

6. PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages

Website link to discussion topic: https://prst.ie/1vq

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 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 -

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-

ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle-

WHO Cleaning Guidance -

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 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 Pharmacist

Kevin Hansen, PharmD, Assistant Director of Pharmacy

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 edition of the QRM Series Stacey, Lori, and Nuala are joined by Chris Flask. The team are going to take a look at risk management in the broader context and get some facts straight!

De-risking your supply chain: http://www.ivtnetwork.com/sites/default/files/NUALA-IVT%20Network%20-%20De-risking%20Your%20Supply%20Chain.pdf

Risk Assessment Steps for Success: http://www.ivtnetwork.com/sites/default/files/NUALA-Risk Assessment Steps for Success_PRST@TUDublin and BioPharmChem Ireland.pdf

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.