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ANALYTICAL PROCEDURES & METHODS VALIDATION

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Develop, Implement and Maintain Processes that Survive the Product Life Cycle

June 17 - June 19

Philadelphia, United States

Analytical Procedures & Methods Validation

 

The time has never been greater to stay up-to-speed with current regulatory thinking. Between FDA’s newly released guidance on Bioanalytical Method Validation and the flurry of global regulations on data integrity, it is critical for you and your company to receive the training you need and avoid regulatory action. FDA, ICH and USP all recognize Analytical Development and Validation as top priority in the drug development process and each have respective guidance, albeit interpretation is left to industry. Not only does this event take a deep dive into how companies comply with regulations, but also showcases how leading companies develop methods, validate procedures and generate data and information that lead to critical business decisions. This conference takes participants through a best practice journey through the development, validation and transfer of analytical methods

 

Choose from Over 20 Tutorials Addressing Today’s Top Analytical Challenges

 

Analytical Procedures and Methods Validation

  • Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
  • Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
  • Define and Develop the Content and Scope of Analytical Procedures Program
  • Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
  • Develop a Roadmap for Analytical Methods Validation
  • Evaluate Characteristics through Statistical Analysis of Validation Data
  • Development and Validation of a Stability-Indicating Analytical Method
  • Learn How to Perform Risk-Based Evaluations
  • Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • Handle the FDA Laboratory Methods Verification Process
  • Effectively Manage Transfer Studies and Protocols

 

This Conference is Co-located with Laboratory Data Integrity Congress!

  • Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide
  • Learn the Methodology and Techniques Used to Identify Inaccuracies
  • Conduct an Laboratory Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Identify and Investigate Root Causes of Integrity Lapses
  • Cybersecurity Risk Management Implementation and Continued Verification
  • Perform a Risk Assessment for  Data Deficiencies
  • Understand Requirements and How to Handle Laboratory Audit Trails

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Scientist
  • Chemist
  • Laboratory Management
  • Regulatory Affairs
  • Data Integrity

 

This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, 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 PEAK AT THE AGENDA

Agenda

  • 12:00
    Conference Registration
    Coffee & Lite Snacks On-the-Go
  • 1:15 PM
    GENERAL SESSIONS
  • Qualification of Reference Standards, Controls and Reagents
    Grainne Tobin, Biologist, OCBQ, CBER, U.S. FDA
  • The GMP Pharmaceutical Laboratory – An FDA Perspective
    Gayle Lawson, PreApproval Manager, OPQO, U.S. FDA
  • 3:00 PM
    Afternoon Refreshment Break
  • 3:30 PM
    GENERAL SESSIONS
  • Lifecycle Management Concepts to Analytical Procedures
    Alfred Del Grosso, Ph.D., Formerly, Chemist, Team Leader, CBER, FDA
  • FDA’s New Data Integrity Guidance and the GMP Lab
    Chris Wubbolt, Principal, QACV
  • 5:00 PM
    KENX/Temple Scholarship Award & Welcome Reception
  • 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, 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)
    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
    Select From Focus Group Luncheons
  • (Analytical)
    The Lifecycle Management Paradigm Shift for Analytical Procedures
    Peju Odunusi, Ph.D., Stability Group Leader, Abbott
  • (Data Integrity)
    Maintaining Data Integrity During Laboratory Investigations
    To Be Announced
  • (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 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)
    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
    Afternoon Refreshment Break
  • 3:15-4:45 PM
    Select Between Knowledge Exchange Sessions
  • (Analytical)
    Conduct Analytical Transfer and Comparability Studies
    Junghae Scott, J Scott Consulting
  • (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, 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)
    Data Integrity Across Paper, Electronic and Hybrid Systems
    Kim Huynh-Ba, Managing Director, Pharmalytik
  • (Stability)
    n-Use Testing Requirements for the Patient
    Steven Kuwahara, Ph.D. Principal Consultant, GXP BioTechnology
  • (Stability)
    Applying Iso-Conversion Stability Results to Regulatory Submissions
    To Be Announced
  • 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 PM
    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
    Jian Liu, Ph.D., Senior Staff Scientist, Abbott

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.
  • Eileen Cortes, Associate Director for QA and Validation, BioMarin

    Eileen Cortes is an Industrial Engineer and MBA professional with over fifteen years of experience in the biotech and pharmaceutical industry. Currently driving the computerized system global validation program as the QA CSV Associate Director at BioMarin.
  • Alfred Del Grosso, Ph.D., Formerly, Chemist, Team Leader, CBER, FDA

  • Kim Huynh-Ba, Managing 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.”
  • Steven S. 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.
  • Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience

    Mr. LaPierre is an industry expert and an experienced data integrity project manager. He has a thorough understanding of not only the foundation and principles of data integrity but also the project management tools and resources needed to execute a truly effective data integrity program in the life science industry.
  • Gayle Lawson, PreApproval Manager, OPQO, U.S. FDA

    CDR Gayle Lawson is an officer with the US Public Health Service in the Pharmacy Category. At her assigned duty station with FDA in Philadelphia, CDR Lawson is a Drug Specialist and serves as the Pre-Approval Manager and primary Field Alert Report Monitor. She has been an Investigator for over 17 years and has conducted domestic and foreign inspections across several commodity areas with a focus on drugs and biologics. CDR Lawson’s duties as an active duty US Public Health Service Officer also include serving as a member of an emergency response team to shelter persons with medical needs who are displaced or evacuated during emergencies. In her first commissioned assignment, CDR Lawson served as the Chief Pharmacist at a federal prison with the Federal Bureau of Prisons. Prior to her federal service, CDR Lawson graduated from Rutgers University College of Pharmacy and practiced community pharmacy for 17 years.
  • Jennifer Lewis, Ph.D., Senior Associate Director, FreeThink Technologies

    Dr. Lewis is responsible for all aspects of laboratory management, direct client-sponsored project work, and helping develop and spearhead FreeThink’s R&D strategy. She has over ten years of experience developing and validating analytical test methods, particularly chromatography methods, for both small molecule drugs and biologics in the pharmaceutical industry. She has expertise in a wide-range of analytical methodologies to support product release testing, stability testing, new product formulation, patent protection and unknown impurity identification. Dr. Lewis received her B.A. degree in chemistry from Berea College and her Ph.D. in bioanalytical chemistry from the University of Kentucky.
  • Greg Martin, President, Complectors Consulting

    Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 30 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 20 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Lifecycle of Analytical Procedures, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.
  • 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.
  • Dhruvin Patel, Manager, Change Control & Documentation, Allergan

    Mr. Patel is an experienced team leader with over ten years of experience in process validation, method validation, CSV, GAMP 5, and 21 CFR Part 11. He has successfully managed transitions from paper to electronic systems as well as implementation of risk-based approaches to improve system utilization. He is an ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and a Lean Six Sigma Green Belt.
  • Lina Patel, Ph.D., Director, Quality Operations, Merck

    Dr. Lina Patel is a nationally recognized leader within and beyond the field of biopharmaceuticals possessing more than 20 years in the pharmaceutical & biotechnology industry. She is currently Director of Quality Operations Technical at Merck & Co., Inc. in Durham, NC. Before joining Merck, Dr. Patel was at Fujifilm Diosynth Biotechnologies (formerly, Covance, Akzo Nobel, Diosynth, Schering Plough, and Merck) in Research Triangle Park, NC, holding leadership positions in the Lean Six Sigma group and the Quality Control Laboratories with responsibilities spanning Stability, Clinical Release, Raw Materials and Analytical (Chemistry & Biochemistry) Testing. She received her Ph.D. in Biochemistry from North Carolina State University and her post-doctoral training in Molecular Genetics at the National Institute of Environmental and Health Sciences (NIEHS).
  • Chinmoy Roy, Industry Consultant, ValGenesis, Inc.

    Chinmoy Roy is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Master’s degree in Computer Science.
  • Leonel M. Santos, Formerly, Analytical Chemist, U.S. Pharmacopeia

    Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 30 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 20 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Lifecycle of Analytical Procedures, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.
  • 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.
  • Ronald D. Snee, Ph.D., President, Snee Associates, LLC

    Ron Snee is Founder of Snee Associates, LLC, a firm dedicated to the successful implementation of process and organizational improvement initiatives, using Quality by Design, Lean Six Sigma and other improvement approaches. He is also an Adjunct Professor in the RAQA and pharmaceutical programs at Temple and Rutgers Universities. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceutical development. He is an Honorary Member of the American Society for Quality and has received numerous honors and awards for his research, consulting and publications.
  • Grainne Tobin, Biologist, OCBQ, CBER, U.S. FDA

    Grainne Tobin is a Biologist in the Division of Biological Standards and Quality Control (DBSQC) in the Office of Compliance and Biological Quality (OCBQ) in CBER. She received her Ph.D. in Biochemistry and Molecular Biology from the Medical College of Ohio. Her postdoctoral studies were carried out at the American Red Cross in Rockville, MD. She was a Research Scientist in EntreMed, Inc., Rockville, MD and moved to the FDA in 2009, joining the Division of Applied Regulatory Science (DARS) in CDER as an ORISE Fellow. She joined DBSQC in 2013, where she has worked in the Laboratory of Analytical Chemistry and Blood Related Products, with her efforts being focused on the CMC review of BLAs and lot-release testing of blood related products and blood donor screening kits.
  • Chris Wubbolt, Principal, QACV

    Chris Wubbolt is a Certified Six Sigma Black Belt, has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. Mr. Wubbolt was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.
  • 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.

Sponsors

  • GOLD





  • 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

Details

Start:
June 17
End:
June 19
Event Category:
Website:
https://www.kenx.org/events/analytical-validation/

Venue

Wyndham Philadelphia
400 Arch Street
Philadelphia, PA 19106 United States
+ Google Map
Phone:
(215) 923-8660
Website:
https://book.passkey.com/e/49825646

Pricing & Registration

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