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STABILITY TESTING & PROGRAM MANAGEMENT

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Implement Best-In-Class Procedures through the Product Life Cycle

June 17 - June 19

Philadelphia, United States

Stability Testing & Program Management Excellence

 

Stability testing is critical to the efficacy of drug substances. ICH, FDA and WHO stability guidance’s have been around for quite some time and are strictly enforced, however, industry still has challenges to overcome and seeks more direction. The time has never been more critical to evaluate your program and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators.  KENX is pleased to announce that our comprehensive Stability Testing & Program Management is headed to Philadelphia to showcase programs and procedures that excel and avoid regulatory action.

 

Stability Leaders Showcase Best-In-Class Programs

 

  • Develop and Validate Stability-Indicating Analytical Methods
  • Learn How to Perform Risk-Based Stability Testing
  • Walk through a Case Study for Stability Testing of New Drug Substances and Products
  • Establish Change Control Procedures for Stability Programs
  • OOS/OOT – Learn How to Handle Testing Variation
  • eStability – Automate Drug Stability Reporting Validation Procedures
  • Use Container Closer System Integrity Testing as a Stability Protocol
  • Apply Bracketing and Matrixing Designs for Testing
  • Evaluate overall Photosensitivity through Forced Degradation Testing Studies
  • Biologic Case Study – Establish Testing Limits for Standardized Grass Pollen Extracts
  • Discover the Most Effective Approach for Evaluating Stability Data
  • Stability Data Integrity – Implement a Governance Program
  • Manage Storage Conditions in Zones III and IV
  • Predict Shelf Life through Accelerated Testing
  • FDA Inspections – Prepare for an FDA Audit
  • Case Study – Implement a Stability Program for Medical Device Manufacturing

 

Personnel in the Following Environments Should Attend:

  • Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device
  • QA/QC
  • Stability Laboratories
  • Raw Materials
  • Laboratory Management
  • Regulatory Affairs
  • Formulation

This event is also appropriate to business development and sales managers that offer innovative solutions for QC testing laboratories, data collection, and statistics.

 

For an additional $995, you can earn 1.5 graduate credit hours towards Temple’s RAQA Graduate Program! For more information on the Temple Track for Lab University, email info@kenx.org, or call 856-281-7134.

 

CLICK HERE FOR A SNEAK PEEK AT THE AGENDA

Agenda

  • 12:00 PM
    Conference Registration
    Coffee & Lite Snacks On-the-Go
  • 1:15 PM
    GENERAL SESSIONS
  • (Stability)
    Navigating the Maze of Stability Regulations
    John O’Neill, Stability Information Specialist, Nagano Science
  • (Stability)
    Shelf-Life Prediction through Accelerated Stability Assessment Program
    Maria Krisch, Ph.D., Senior Scientist, FreeThink Technologies, Inc.
  • (Analytical & Data Integrity)
    Qualification of Reference Standards, Controls and Reagents
    Grainne Tobin, Biologist, OCBQ, CBER, U.S. FDA
  • (Analytical & Data Integrity)
    The GMP Pharmaceutical Laboratory – An FDA Perspective
    Gayle Lawson, PreApproval Manager, OPQO, U.S. FDA
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:30 PM
    GENERAL SESSIONS
  • (Stability)
    Meeting Data Integrity Challenges in Stability Testing
    Steven Kuwahara, Ph.D. Principal Consultant, GXP BioTechnology
  • (Stability)
    Post Approval Changes for Test Methods and Specifications
    Jian Liu, Ph.D., Senior Staff Scientist, Abbott
  • (Stability)
    Transitioning from Manual to Electronic Systems
    Sheba Zaman, Head of Product Specialists and Training Services, Novatek
  • (Analytical & Data Integrity)
    Lifecycle Management Concepts to Analytical Procedures
    Alfred Del Grosso, Ph.D., Formerly, Chemist, Team Leader, CBER, FDA
  • (Analytical & Data Integrity)
    FDA’s New Data Integrity Guidance and the GMP Lab
    Chris Wubbolt, Principal, QACV
  • (Analytical & Data Integrity)
    Methods Verification – Determine Suitability for Intended Use
    Greg Martin, President, Complectors Consulting
  • 5:00 PM
    KENX/Temple Scholarship Award & Welcome Reception
  • Close of Day One
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30 – 8:15 AM
    Select Between Knowledge Exchange Breakfast Discussion
  • (Analytical)
    Verification of Compendial Procedures
    Leonel M. Santos, Formerly, Analytical Chemist, U.S. Pharmacopeia
  • (Data Integrity)
    Understand the Human Impact in the QC Laboratory
    Lina Patel, Ph.D., Director, Quality Operations, Merck
  • (Stability)
    Reduced Study Designs for Registration Stability Programs
    Geoff Carr, Ph.D., Director, Analytical Development, Thermofisher Patheon
  • 8:30-10:00 AM
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Case Study – Life Cycle Management of Analytical Procedures
    Greg Martin, President, Complectors Consulting
  • (Data Integrity)
    Building a Laboratory Data Integrity Program from the Ground Up
    Chris Wubbolt, Principal, QACV
  • (Stability)
    A Roadmap to Establish, Manage and Improve a Stability Program
    Chris Latoz, Manager Stability & Analytical Services, Hollister Incorporated
  • 10:00 AM
    Networking Refreshment Break
  • 10:30-12:00
    Select Between Knowledge Exchange Sessions
  • (Analytical & Data Integrity)
    Minimize Data Integrity Concerns of Analytical Methods with Method Lifecycle Management
    Heather Longden, Senior Marketing Manager, Waters Corporation; Isabelle Vu Trieu, Pharmaceutical Market Development Manager, Waters Corporation
  • (Analytical)
    Implement a Compliance Training Program for Laboratory Personnel
    Lina Patel, Ph.D., Director, Quality Operations Technical Services, Merck
  • (Data Integrity)
    Good Documentation Practices to Maintain Data Integrity in the Laboratory
    Kim Huynh-Ba, Managing Director, Pharmalytik
  • (Stability)
    Conduct OOS and OOT Investigations for Analytical Testing
    Emily S. D. Trubee, MS, Stability Manager, ADARE Pharmaceuticals
  • 12:00 PM
    Select From Focus Group Luncheons
  • (Analytical)
    The Lifecycle Management Paradigm Shift for Analytical Procedures
    Peju Odunusi, Ph.D., Stability Group Leader, Abbott
  • (Data Integrity)
    The GMP Pharmaceutical Laboratory – Ask the FDA
    Gayle Lawson, PreApproval Manager, OPQO, U.S. FDA
  • (Data Integrity)
    Data Integrity in a Laboratory – A Case Study Review
    John Hannon, Global Principal for Automation and IT, CAI
  • (Stability)
    Develop an Enthusiastic Continuous Improvement Strategy
    John O’Neill, Stability Information Specialist, Nagano Science
  • (Stability)
    In-Use and Excursions – Stability beyond ICH
    Maria Krisch, Ph.D., Senior Scientist, FreeThink Technologies, Inc.
  • 1:15–2:45 PMP
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Conduct Analytical Transfer and Comparability Studies
    Junghae Scott, J Scott Consulting
  • (Data Integrity)
    Impact of Human Factors on Data Integrity in the Laboratory
    Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience
  • (Stability)
    Using QRM to Establish Critical Quality Attributes
    Kim Huynh-Ba, Executive Director, Pharmalytik
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:15-4:45 PM
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Risk-Based Approach to Test Method Validation
    Ronald D. Snee, Ph.D., President, Snee Associates, LLC
  • (Data Integrity)
    Conduct an Audit and Gap Analytical of Lab Computerized Systems
    Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience
  • (Stability)
    FDA Inspection Readiness – Conduct Audits/Manage Investigations
    Peju Odunusi, Ph.D., Stability Group Leader, Abbott | Junghae Scott, J Scott Consulting
  • 4:45 PM Day Two Closing Session
    Considerations for Using Spreadsheets in the GMP Lab Environment
    Sanjay Agrawal, President and CEO, CIMINFO Software
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30–8:15 AM
    Select Between Knowledge Exchange Breakfast Discussion
  • (Analytical)
    Method Variation – Handling Measurement Uncertainty
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
  • (Data Integrity)
    Laboratory Audit Trail Reviews – Know FDA’s Expanded Requirements
    Dhruvin Patel, Manager, Change Control & Documentation, Allergan
  • (Stability)
    Conducting Forced Degradation Studies
    Geoff Carr, Ph.D., Director, Analytical Development, Thermofisher Patheon
  • 8:30-10:00 AM
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Development and Validation of Stability-Indicating Analytical Methods
    Jennifer Lewis, Ph.D., Senior Associate Director, FreeThink Technologies
  • (Data Integrity)
    Lab Data Integrity Risk Assessments – Using Process Flow Charts
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • (Stability)
    Stability Budgeting and Cost Management
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • 10:00 AM
    Mid-Morning Refreshment Break
  • 10:30-12:00
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Implementation of Continued Process Verification in the Lab
    Ronald D. Snee, Ph.D., President, Snee Associates, LLC
  • (Data Integrity)
    Impact of Data Integrity Guidance on OOS Investigation
    Kim Huynh-Ba, Managing Director, Pharmalytik
  • (Stability)
    Statistical Process Control and The Use of Control Charts
    Douglas B. Brown, Ph.D., Senior Scientist, Charles River Laboratories, Inc.
  • 12:00
    Select From Focus Group Luncheons
  • (Analytical)
    Establishing Acceptance Criteria for System Suitability Testing Limits
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • (Data Integrity)
    Ensure Data Quality and Integrity Over the Lifecycle of the Method
    Heather Longden, Senior Marketing Manager, Waters Corporation | Isabelle Vu Trieu, Pharmaceutical Market Development Manager, Waters Corporation
  • (Data Integrity)
    Data Integrity Across Paper, Electronic and Hybrid Systems
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • (Stability)
    In-Use Testing Requirements for the Patient
    Steven Kuwahara, Ph.D. Principal Consultant, GXP BioTechnology
  • (Stability)
    Data Integrity Deep Dive for an Electronic Stability Solution
    Sheba Zaman, Head of Product Specialists and Training Services, Novatek
  • 1:15–2:45 PM
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Evaluate Method Validation Factors with Simple Statistical Methods
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
  • (Data Integrity)
    Qualification and Data Integrity Compliance of Lab Instruments
    Chinmoy Roy, Industry Consultant, ValGenesis, Inc.
  • (Stability)
    Stability Data Integrity – Build a Governance Program from the Ground Up
    Emily S. D. Trubee, MS, Stability Manager, ADARE Pharmaceuticals
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:15–4:45 PPM
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Overcome the Misinterpretation of Analytical Assay Data
    Douglas B. Brown, Ph.D., Senior Scientist, Charles River Laboratories, Inc.
  • (Data Integrity)
    Quality Cultures that Identify and Address Risks
    Dhruvin Patel, Manager, Change Control & Documentation, Allergan
  • (Stability)
    Case Study – Stability Program for Combination Products
    Jian Liu, Ph.D., Senior Staff Scientist, Abbott
  • 4:30 PM
    Close of Conference

Faculty

  • Sanjay Agrawal, President and CEO, CIMINFO Software

    Sanjay Agrawal is President and CEO of CIMINFO Software. He has over 25 years of experience in Computer Systems Validation, and Data Integrity Compliance. Early in his career, Sanjay pioneered risk-based validation methodologies for large scale enterprise systems such as ERP by developing a data framework, and identifying the controls necessary for each data category. He has developed facility-wide Master Validation Plans that included systems, people, and processes and managed validation projects for systems at every level ranging from spreadsheets/databases, PLCs and equipment to LIMS, HPLC, SCADA, MES and ERP. Sanjay is also a pioneer in introducing Part 11 compliance technologies for spreadsheets and Access databases to the industry that are in use today at hundreds of FDA-regulated firms worldwide.
  • Douglas B. Brown, Ph.D., Senior Scientist, Charles River Laboratories, Inc.

    Douglas B. Brown, Ph.D. is a Sr. Scientist at Charles River Laboratories, Biologics Testing Solutions Division. For over 15 years, he had been a lead scientist for the development of molecular-based assays utilized in the detection and identification of viruses, bacteria, residual host-cell DNA, and other contaminating agents which may be transferred during a manufacturing purification process. Throughout the last 10 years, Dr. Brown has also been focusing his efforts on process and efficiency improvement within the GMP environment as well as developing, improving, and optimizing test method verification, qualification, and validation processes and procedures.
  • Geoff Carr, Ph.D., Director, Analytical Development, Thermofisher Patheon

    Geoff Carr was appointed as Manager, Analytical Development at Patheon Inc, Canada in 2000 and is now Director, Analytical Development, Thermofisher Patheon. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. He has been a Member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia and Member of USP Committees and is currently a Member of the 2015-2020 Cycle USP General Chapters – Physical Methods Expert Committee. He is the author of numerous papers, presentations at international conferences and workshops on various topics related to Pharmaceutical Analysis and particularly on the subject of Conducting Stability Studies
  • John Hannon, Business Lead Automation and IT, Commissioning Agents, Inc.

    John Hannon is an Executive Consultant and Business Area Leader for Automation and IT at Commissioning Agents. With over 29 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Baxter, Monsanto, Amgen, Genentech, Pfizer, and Cook. He has managed multi-million dollar projects and project teams across the US and Europe, and is responsible for delivering hundreds of high-profile, mission-critical projects for biotech, pharmaceutical, and medical device customers. Currently he leads CAI's IT and Automation business area - responsible for the development of automation, MES, and other IT system projects within the international client base. With a demonstrated knowledge of quality assurance and regulatory compliance across the pharmaceutical industry, Mr. Hannon has led national and international seminars with ISPE, contributed to several publications such as Pharmaceutical Technology, and has led speaking venues related to risk-based approaches to smarter integrated system delivery compliant to the FDA, USDA, and EU regulatory agencies. He is an active and sought-after consultant for complex IT and automation problems in the pharmaceutical industry. Mr. Hannon holds a Bachelor of Science in Electrical Engineering from Georgia Tech, has completed studies at Harvard Business School, is a Certified Pharmaceutical Industry Professional and holds Professional Engineering certification in the state of North Carolina. Most recently he has worked with pharmacetical clients to resolve data integrity related regulatory citings.
  • John Henchion, Global Director of Quality, Compliance and Regulatory, CAI

    John has more than 25 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John has extensive analytical experience and has led multiple analytical transfer projects. John is a passionate advocate for QRM and smart efficient QRM integration within the Biopharma Industry. John is a Quality Systems SME. He has in-depth understanding of aseptic processing, biotechnology products (MABs and other therapeutic proteins), sterilization, lyophilization, liquid fill, oral solid dosage, of tech transfer, supply chain qualification, bulk chemical API and medical devices. He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications including technical transfers. John has significant experience in GMP/ISO auditing of manufacturing facilities and supply chain.
  • Kim Huynh-Ba, Executive Director, Pharmalytik

    Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has almost 30-years of experience in the Quality System environment, strategic drug development and stability sciences. She is a Council of Expert of US Pharmacopeia (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel as well as the former chair of the USP Good Documentation Practices Expert panel. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology where she teaches Quality Audits, GMPs, ICH Quality Guidelines and Pharmaceutical Analysis. She is the editor of the two well-known stability handbooks; “Handbook of Stability Testing of Pharmaceutical Products” and “Stability Testing to Support Global Markets.” She is also completing a new manuscript entitled “Analytical Chemistry: A Handbook of Pharmaceutical GMP Laboratories.”
  • Maria Krisch, Ph.D., Senior Scientist, FreeThink Technologies, Inc.

    Maria Krisch is a Senior Scientist at FreeThink Technologies, Inc. where she is responsible for leading company projects focused on chemical and physical stability. Dr. Krisch received her B.A. in chemistry from Swarthmore College and her Ph.D. in physical chemistry with a focus on molecular dynamics from the University of Chicago (as an NSF Graduate Research Fellow). She conducted post-doctoral research in physical chemistry at the University of California, Irvine, studying the surface structure and reactivity of liquids. Dr. Krisch served on the faculty and led a research group at Trinity College in Hartford, CT for eight years before joining FreeThink Technologies, Inc. in 2017. She is a co-author on over 20 publications.
  • Steven Kuwahara, Ph.D. Principal Consultant, GXP BioTechnology

    Steven S. Kuwahara, Ph.D., is principal consultant at GXP BioTechnology, LLC (www.gxpbiotech.org) in Sunnyvale, CA. Steve has more than 30 years experience supervising quality control department dealing with drugs, biologics, HCT/P, and nutraceuticals. He has supervised animal facilities and testing laboratories that operated under GLP rules and also those operating under GMP and ISO standards. He may be reached by e-mail and by phone at 408-530-9338.
  • Chris Latoz, Manager Stability & Analytical Services, Hollister Incorporated

    Christopher (Chris) V. Latoz is Manager, Stability and Analytical Services at Hollister Incorporated in Libertyville, IL. Chris has over 25 years’ experience in the medical device industry (Class I and II devices) working in R&D, Technical Services, and more recently, Stability. While at Hollister, Chris has led several process and capacity improvement projects, including: the implementation of a LIMS (Laboratory Information Management System) for stability sample and data management; the construction of new walk-in stability storage chambers; and the implementation of a temperature and humidity monitoring system for stability chambers.
  • Jian Liu, Ph.D., Senior Staff Scientist, Abbott

    Dr. Liu currently is a manager of stability department in the Analytical Chemistry Research and Technology of Abbott Vascular. Dr. Liu has over 20 years of extensive experience of analytical chemistry and stability program in the pharmaceutical and medical device industry. His pharmaceutical industry experience at Watson Pharmaceuticals focused on analytical chemistry for solid dosage products. Dr. Liu’s medical device industry career at Abbott Vascular (formally Guidant) started in analytical method development, validation and transfer for Drug Eluting Stents (DES) products.
  • Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation

    After a number of years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products. This involves helping design the compliance into our informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.
  • Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals

    Bette has a strong background in drug development in the areas of analytical method development, stability, formulation, validation, and vendor management. Her main responsibilities included stability, product development and associated analytical testing, as well as preparation of regulatory CMC documents for global filings. Working for small Pharma that adopted a virtual model - outsourcing all CMC activities to third party vendors, Bette has extensive experience managing the need of her projects and the vendor’s needs, which is necessary to delivery high quality analytical methods, robust formulation and critical stability data to support the product in a global clinical or commercial marketplace.
  • Peju Odunusi, Ph.D., Stability Group Leader, Abbott

    Dr. Peju Odunusi is an analytical R&D professional with over 23 years of experience in the pharmaceutical and medical device industries. She has technical expertise in method development and validation, stability support for all phases of product development, method transfer, submissions, audits and has successfully established analytical and stability groups. She is also very passionate about mentoring.
  • John O’Neill, Stability Information Specialist, Nagano Science

    John O’Neill has a degree in Pharmaceutical Sciences from Columbia University and a Masters in Health Systems Management from Union University. John’s career has taken him through pharmaceuticals, medical devices and biologicals. As president of John ONeill Enterprises LLC, he currently serves as Stability Information Specialist for Nagano Science LTD. For the past 30 years, John has been the Facilitator of the Pharmaceutical Stability Discussion Group, which has made him privy to just about everything that can go right or wrong with the Stability function.
  • Junghae Scott, J Scott Consulting

    Ms. Junghae Scott is an industry consultant. Previously, Ms. Scott was a Director of Quality Control at Relypsa in Redwood City, California (a Vifor Pharma Group company). Ms. Scott has 30 years of industry experience in CMC, analytical development, and quality control covering Pharma, Biotech, Medical Device, and Combination Products from start-ups to Fortune 500 companies. She received her Master Degree in Chemistry at University of San Francisco.
  • Emily S. D. Trubee, MS, Stability Manager, ADARE Pharmaceuticals

    Ms. Trubee is a pharmaceutical professional with 14 years of experience in Quality Control, and Stability Testing and Management, with a focus on regulations-compliant stability programs for sterile injectables, solid oral dosage forms, and biological products. In her current role as Stability Manager, Research and Development at Adare Pharmaceuticals, she is responsible for managing the stability lifecycle of all products from pre-clinical through commercialization. Emily earned her Bachelor of Science degree in Chemistry from Wilmington College in Wilmington, OH and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.
  • Sheba Zaman B.S. in Computer Science Head of Product Specialists and Training Services Novatek International

    Sheba Zaman has been serving in a technical role at Novatek International for over 17 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade to establish procedures, work instructions, validation scripts and training program related to their data management systems.
  • Isabelle Vu Trieu, Pharmaceutical Market Development Manager, Waters Corporation

    Isabelle’s mission is to deliver benefits to analytical scientists in the pharma industry. She joined Waters in 2009 as a Supercritical Fluid Technology Specialist before transitioning to a Business Development Manager role. Prior to Waters, she held positions at Thar Instruments, Mettler Toledo and Phenomenex. Originally from France, Isabelle obtained a MS in Chemical Engineering from the University of Lyon in France (1998), and then she moved to New York City and pursued graduate studies in Chemistry at Columbia University. She earned a MA in Chemistry and joined the teaching staff at Columbia University for one academic year.
  • Shirley Wong, Informatics Field Marketing, Waters Corporation

    Shirley has worked Waters since 2001 with roles ranging from Mass Spectrometry Software Technical Support, Informatics Systems Engineer, and project management. In her current role she focuses on customers’ needs around laboratory processes in a regulated laboratory. She holds a Bachelor of Science degree in Chemistry from University of California at Berkely and is certified Project Manager through PMI.
  • Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation

    After several years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance to pharmaceutical e-record regulations, acting as a resource to the Waters Global Community and users of all Waters products. This involves helping design compliance into Waters’ Informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations, and disseminating this information to the Waters field and corporate organizations.
  • John Henchion, Global Director of Quality, Compliance and Regulatory. CAI.

    John has more than 25 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John has extensive analytical experience and has led multiple analytical transfer projects. John is a passionate advocate for QRM and smart efficient QRM integration within the Biopharma Industry. John is a Quality Systems SME. He has in-depth understanding of aseptic processing, biotechnology products (MABs and other therapeutic proteins), sterilization, lyophilization, liquid fill, oral solid dosage, of tech transfer, supply chain qualification, bulk chemical API and medical devices. He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications including technical transfers. John has significant experience in GMP/ISO auditing of manufacturing facilities and supply chain.

Sponsors





  • We believe that world class operations successfully plan and integrate three areas: product/process/end-user requirements; people; and equipment/automation/facility technology. All of our services focus on integrating these areas necessary for successful operations, as applied to regulated manufacturing, mission critical facilities, energy-efficient buildings, patient-critical facilities, and complex operations.

  • From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions. Waters Corporation is the world's leading specialty measurement company focused on improving human health and well being through the application of advanced analytical science technologies.
    Website: http://www.waters.com
  • SILVER





  • AVQC, Array Validation Quality & Compliance, Inc. is a Multinational Life Sciences Global Compliance Consulting Firm with 25 + years experience delivering Technical Writing and Validation Services in the Pharmaceutical, Medical Device, Biotechnology and Food Industries.
    Website: https://www.avqc.com/
  • Trusted by hundreds of FDA-regulated firms in over 30 countries, CIMINFO provides Data Integrity and 21 CFR Part 11 compliance solutions that reduce compliance costs and improve efficiency. Existing spreadsheets and Access databases can be made Part 11 compliant with minimal effort. Enterprise products automate business processes such as data integrity management/auditing, document management, engineering data/drawing controls, and training.
    Website: https://part11solutions.com/
  • Novatek International’s mission is to produce regulatory compliant software solutions to the pharmaceutical, biotech and other health-care industries. Our goal is to improve patient safety by producing solutions that reduce the risks associated with pharmaceutical manufacturing and contribute to product quality.

    Since 1996, Novatek International has been a global leader in providing innovative and comprehensive, process-driven software solutions. With 20 years of successful global installations Novatek has developed an extensive base of regulatory knowledge giving you the peace of mind knowing you are in compliance with regulatory guidelines. Your Data is more than just a number. It has the power to drive compliancy and improve your business.
    Website: https://ntint.com/
  • H&A Scientific, Inc. is a scientific software development firm specializing in pharmaceutical industry support. We develop, validate, and market quality computing systems for scientific data acquisition, processing, and data management. We have been creating programs for the laboratory since 1992. Our products have been designed under our Quality System to adhere to the current GAMP guidelines. We develop Quality Software products based on the needs of pharmaceutical companies subject to the constraints and compliance of the Food and Drug Administration (FDA). Our flagship product, SLIM, is a commercial off-the-shelf solution for total management of a company's drug stability program.
    Website: http://www.hascientific.com/en/
  • QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization.
    Website: http://www.qacvconsulting.com/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

Venue

Venue

Wyndham Philadelphia Historic District
400 Arch Street
Philadelphia, PA 19106 United States
+ Google Map
Phone:
(215) 923-8660
Website:
https://book.passkey.com/event/49826319/owner/16417/home

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