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VALIDATION AND GMP UNIVERSITY

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Continued Verification * Master Planning * Risk * Statistics * Change Control * Data Integrity

August 24 - August 26

Philadelphia, United States



VALIDATION UNIVERSITY RETURNS TO PHILADELPHIA!

Knowledge Exchange Network (KENX) is very excited to announce Validation University is returning to Philadelphia. The event is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create-their-own-experience by choosing from over 40 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges. Val-U offers a hands-on experience in which lessons learned turn into immediate, actionable results.  

 

40 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe

 

Facility Commissioning & Equipment Qualification

  • Implement a Risk-based Verification Strategy
  • Design a Risk-based IQ, OQ, and PQ Approach
  • Manage Process Validation Tech Transfers
  • Qualify Critical Utility Systems – HVAC, Water and Gas

 

Process Validation

  • Learn How To Use Statistics in Validation – Statistics for Non-Statisticians
  • Implement a 3-Stage Process Validation Approach
  • Master the Validation Master Plan (VMP)
  • Conduct Risk-based Continued Process Verfications

 

Cleaning Validation

  • Understand Key Elements to a Successful Program
  • Establish Cleaning Residue Limits and Acceptance Criteria
  • Establishing Bioburden and Endotoxin limits for Sterile and Non-sterile Products and Processes
  • Receive a Cleaning Validation Assessment Checklist Example

 

Computer System Validation

  • Stay up to speed with FDA’s Computer Software Assurance proposed draft
  • Implement a Risk-Based CSV Program Enterprise-Wide
  • Develop and Validate SAAS, IAAS, and Other Software Programs
  • Qualify Network Infrastructure and Cloud Environments

  

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • C&Q
  • Regulatory and Compliance
  • Facility Management
  • Manufacturing
  • Laboratory

 

This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.

 

This Conference is Co-Located with DATA INTEGRITY INSPECTION READINESS SUMMIT with In-Depth Coverage On:

  • Understand the Human Factor for Compliance
  • Learn How to Build a Program from the Ground Up
  • Identify the Root Cause of Inaccuracies
  • Conduct an Audit/Gap Assessment and Implement Corrective Action
  • Comply Across the GxP Environment
  • Benchmark With Manufacturing, Laboratory and Clinical Top Companies
  • Address Malicious Threats through Cybersecurity Best Practices
  • Conduct Data Integrity Risk Assessments
  • Know How to Handle Audit Trails

 

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.

 

Agenda

  • 12:00 PM EST
    Conference Registration
    Coffee & Tea
  • 1:15 PM EST
    Chairperson’s Opening Remarks
  • 1: 30 PM EST
    FDA Insight – Agency Updates and Compliance Trends
    James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA
  • 2:00 PM EST
    Optimize Your Validation Efforts Using Quality Risk Management
    William T. Drummond Jr., MSCS, Senior Director, Global Computer Validation Quality Assurance, Charles River Laboratories
  • 2:30 PM EST
    Change Control in Validation – Managing Like-for-Like Changes
    Donnacha Nagle; Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals
  • 3:00 PM EST
    Networking Refreshment Break
  • 3:30 PM EST
    Lean Validation – Ensure Quality While Reducing Cost
    Phil Jarvis, Global C&Q lead for EU, Abbvie
  • 4:00 PM EST
    Build a Streamlined Audit Trail Review Process
    Matthew LaPierre, Data Integrity Specialist, Industry Expert
  • 4:30 PM EST
    Examining Validation Training Effectiveness
    Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin Pharmaceutical
  • 5:15 PM EST
    Networking & Welcome Reception
  • 7:00 AM EST
    Coffee and Lite Breakfast
  • 7:30 - 8:15 AM EST
    Select Between Knowledge Exchange Sessions (1-4)
  • 1
    Documentation Requirements for Successful Validation
    Alan Golden, MS, Principal, Design Quality Consultants, LLC
  • 2
    Environmental Monitoring System Design and Validation
    Jason Kelly, Vice President of Services, Lighthouse Worldwide Solutions
  • 3
    Detecting the Lack of Data Integrity
    Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC
  • 4
    Validation Audit Preparation
    Phil Jarvis, Global C&Q lead for EU, Abbvie
  • 8:30 – 10:00 AM EST
    Select Between Knowledge Exchange Sessions (5-9)
  • 5
    The Validation Master Plan (VMP) – Plans That Impress Investigators
    Connie Hetzler, Global Head – Validation, Alcon Laboratories
  • 6
    Risk-Based Cleaning Validation – Key Elements to a Successful Program
    Chip Bennett, Assistant Director, Global C&Q, CAI
  • 7
    Handle Validation Inspections and Respond to Regulatory Findings
    Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP
  • 8
    Cultivate and Maintain the Culture of Integrity in Data Management
    Peju Odunusi, Ph.D., Group Leader, Abbott
  • 9
    Develop, Implement and Maintain a Change Control Program
    Shelley Preslar, President, Azzur Group
  • 10:00 AM EST
    Mid-Morning Refreshment Break
  • 10:30 AM - 12:00 PM EST
    Select Between Knowledge Exchange Sessions (10-14)
  • 10
    Implement a Risk-Based Process Validation Program Enterprise-wide
    Phil Jarvis, Global C&Q lead for EU, Abbvie
  • 11
    Validation Statistics with Confidence and The Arts of Charts
    Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC
  • 12
    A Cost Effective and Practical Approach to Risk-Based CSV
    Michael Brunner, Computer Systems Validation Specialist, Upsher-Smith Laboratories, Inc.
  • 13
    Homo Sapiens atque Integritas Notitia, Expanded Edition – Human Beings and Data Integrity
    J Loren Smith, Senior Manager, Global Compliance & Ethics, BioMarin Pharmaceutical
  • 14
    Handle FDA Inspections and Respond to Regulatory Findings
    Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, United States Pharmacopeia
  • 12:00 PM EST
    Grab & Go Lunch & Learns (15-19)
  • 15
    Accelerate Process Validation with Data-Based Quality by Design
    Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC
  • 16
    Right Size Sampling and Statistics for PPQ
    Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats
  • 17
    Wired vs Wireless – Risks and Rewards of Technologies Related to Validation
    Dennis Plante, Senior Validation Market/Product Specialist, Kaye
  • 18
    Navigate the Maze of Data Integrity Regulations
    Roque Redondo, VP Automation & Business Development, Mirus Consulting Group
  • 19
    Build Your Custom Audit Checklist – Master Class
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 1:15 - 2:45 PM EST
    Select Between Knowledge Exchange Breakfasts (20-24)
  • 20
    Risk-Based Equipment Qualification
    Chip Bennett, Assistant Director, Global C&Q, CAI
  • 21
    Single Use Systems (SUSs) – Implementation and Validation
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
  • 22
    Personnel Training – Hiring People that Make Validation Great
    Patrick Mullin, Senior CQV, QAV Account Manager, DPS Global
  • 23
    Data Integrity Risk Assessment Across the Data Lifecycle
    Chinmoy Roy, Senior Industry Consultant, VALGENESIS
  • 24
    Implementing and Mastering the Critical Elements of a Quality Risk Management Program
    Roque Redondo, VP Automation & Business Development, Mirus Consulting Group
  • 2:45 PM EST
    Afternoon Refreshment Break
  • 3:00 - 4:45 PM EST
    Select Between Knowledge Exchange Sessions (25-29)
  • 25
    Risk-Based Critical Cleaning Process Parameter and Critical Quality Attributes – A Case Study
    Phil Jarvis, Global C&Q lead for EU, Abbvie
  • 26
    Conduct a Gap Analysis of Your Validation Program
    Gamal Amer, Ph.D. Principal, Premier Compliance Services
  • 27
    Qualify Utilities – Water Systems, Clean Steam and Process Gases
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
  • 28
    Validation of Mobile Applications
    Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
  • 29
    Learn How to Use Statistics as a Risk Tool
    Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats
  • 4:45 PM EST
    Day Two Closing Session
  • FDA’s Proposed Computer Software Assurance Guidance
    Kevin Martin, General Manager & Managing Partner, Azzur Group LLC; Senthil Gurumoorthi, Associate Director, Gilead Sciences; Ken Shitamoto, Senior Director, Gilead Sciences
  • 7:00 AM EST
    Coffee and Lite Breakfast
  • 7:30 - 8:15 AM EST
    Select Between Knowledge Exchange Sessions (30-33)
  • 30
    Creating an Effective Supplier Quality Agreement
    Gamal Amer, Ph.D. Principal, Premier Compliance Services
  • 31
    Batch Record Process Automation Using AI for BioPharma
    Abhijit Ray, Chief Digital Architect, Aventior, Inc.
  • 32
    Manage Data Integrity Inspections and Respond to Inspections Findings
    Peju Odunusi, Ph.D. Owner, Pj Pharmaceutical Consulting LLC
  • 33
    Integrate Risk Management into Change Control Processes
    Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
  • 8:30 – 10:00 AM EST
    Select Between Knowledge Exchange Sessions (34-38)
  • 34
    Conduct Risk-Based Revalidations and Periodic Reviews of Systems
    Donnacha Nagle; Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals
  • 35
    Autoclave Validation - Periodic Benchmark Testing
    Chris Maughan, Managing Director and Autoclave SME, Thermal Compliance Ltd
  • 36
    Conduct a Site-Wide Validation Gap Assessment
    Connie Hetzler, Global Head – Validation, Alcon Laboratories
  • 37
    Overcome the Top Challenges of Data Integrity Implementation
    Matthew LaPierre, Data Integrity Specialist, Industry Expert
  • 38
    Conduct a Change Control Impact Assessment
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 10:00 AM EST
    Mid-Morning Refreshment Break
  • 10:30 AM – 12:00 PM EST
    Select Between Knowledge Exchange Sessions (39-43)
  • 39
    Cleaning Validation – Documents, SOPs and Strategies
    Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
  • 40
    Computer Software Assurance Master Class
    Senthil Gurumoorthi, Associate Director; Ken Shitamoto, Senior Director, Gilead Sciences
  • 41
    Medical Device Validation & Verification Master Class
    Alan Golden, Senior CSV and Compliance Manager, Design Quality Consultants, LLC
  • 42
    Implement a Data Infrastructure for Advanced Analytics
    Eric S. Collier, Assistant Director, Automation and IT, CAI
  • 43
    Risk-based Quality Auditing – The Integration of Risk Management Into Quality Audits
    To be announced
  • 12:00 PM EST
    Grab & Go Lunch & Learns (44-47)
  • 44
    Current Trends in Cleanroom Validation
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 45
    Bring Validation into the IT Architecture Life Cycle Process
    Thomas Miller, Senior Enterprise Architect; Christopher Robitaille, CTO, Azzur Group
  • 46
    Transition from Paper to Electronic Validation – Overcome the Challenges
    Kim Munsell, Sr Computer Systems Validation & Compliance Manager, Janssen R&D
  • 47
    Risk Ranking and Filtering for Identification
    To be announced
  • 1:00 - 2:30 PM EST
    Select Between Knowledge Exchange Sessions (48-50)
  • 48
    Process Validation and Successful Tech Transfer
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 49
    Construct and Analyze Validation Control Charts
    Anthony Chikere, Senior Manager, Bayer Pharmaceutical
  • 50
    Create a Validation Strategy for Intelligent Automation
    Steve Thompson, Director Industry Solutions, VALGENESIS, Inc.
  • 2:30
    Afternoon Refreshment Break
  • 2:45 - 4:15 PM EST
    Select Between Knowledge Exchange Sessions (51-53)
  • 51
    HANDS-FREE Validation Using Augmented Reality
    Steve Thompson, Director Industry Solutions, VALGENESIS, Inc.
  • 52
    Validating GXP Spreadsheets
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • 53
    Inspection Management – Root Cause Analysis and Corrective Action (CAPA)
    To be announced
  • 4:30 PM EST
    Close of Conference

Faculty

  • Michael Brunner, CSV Specialist, Upsher-Smith

    Mr. Brunner is experienced with over 14 years of experience in all areas of validation including; equipment validation, facilities validation, CSV and 21 CFR Part 11, and test method validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries.
  • Gamal Amer, Principal, Premier Compliance Services

    Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation.
  • Chip Bennett, Assistant Director, CAI

    Chip Bennett, Assistant Director, Global C&Q, CAI is a QRM SME and lead CQV Program Development SME. A Project Manager and Senior Validation Engineer, Chip is a PMI® Certified Project Management Professional (PMP) with 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.
  • Anthony Chikere, Senior Manager Process Validation/Cleaning And CPV, Bayer HealthCare, Berkeley

    Dr. Anthony Chikere is an experienced scientist with over 15 years of experience in different areas of Biopharmaceutical production including: process development, process monitoring and control, process validation and quality assurance. Since 2017, he is responsible for managing the Continuous Process Verification (CPV) program at Bayer HealthCare in Berkeley.
  • Eric Collier, Discipline Lead Automation And IT, Commissioning Agents, Inc.

    Mr. Collier is an experienced leader with more than 27 years as a project manager, software engineer, and IT consult. More than 17 of those years have been spent in the Pharmaceutical, Biopharmaceutical and Medical Device industries leading 21 CFR Part 11, Computer System Validation (CSV), Data Integrity, and Good Automated Manufacturing Practice (GAMP) assessment, implementation, compliance, and remediation projects.
  • Danielle, Duran, Senior Manager, Training and Development, Site Bus, BioMarin Pharmaceutical

    Danielle has worked in learning and continuous improvement program management in biotechnology, tech-startups, k-16 education, philanthropy, and non-profit. Her expertise is leveraging an understanding of how learning is understood from a neurological perspective combined with how we understand behavior and social interactions to drive meaningful change. Danielle has provided leadership to a research team investigating the use of varied sets of data to predict human performance and a team developing and validating very large-scale knowledge assessments to predict performance. She has also taught assessment design at the graduate level. She is currently leading a global initiative to improve aspects of the training system, standards, and procedures. She enjoys learning, supporting the meaningful development of others, and advising leaders on how to catalyze their talent.
  • Katherine Giacoletti, Partner, SynoloStats, LLC

    Katherine has worked as a statistician in the Pharmaceutical industry for over 17 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics from North Carolina State University, with a focus in biostatistics. Katherine lives and works in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.
  • Alan M Golden, Principal, Design Quality Consultants

    Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
  • Senthil Gurumoorthi MS MBA, Associate Director IT, Gilead Sciences

    Senthil Gurumoorthi leads IT Quality Assurance function at Gilead Sciences, which provides independent oversight for GxP IT Infrastructure & Platforms and manages IT Inspection and audit readiness program. He has over 16 years of diverse experience in biopharmaceutical business ranging from pre-clinical, R&D to manufacturing with leadership expertise on Quality Assurance, Risk Management, Inspection/Audit Management, and Vendor Management. Additionally, as certified Auditor conducted ISO and Part 11/Annex 11 Audits globally. He holds B.E in Electronics & Communication from PSG College of Technology, MS in Electrical Engineering from New Jersey Institute of Technology and Masters in Business Administration (MBA) from Imperial College London.
  • Connie Hetzler, Global Head of Validation, Alcon Laboratories

    Ms. Hetzler has over 32 years of experience working in regulated consumer products and healthcare industry roles. In her current role as Global Head of Validation for Alcon, she is accountable for the validation strategy for 16 manufacturing sites including both the surgical and vision care divisions.
  • Kim Huynh-Ba, Executive Director, Pharmalytik

    Kim Huynh-Ba has over 25 years of experience in quality systems, project management, strategic drug development and stability sciences. She currently is the Executive Director and CEO of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT). She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. Kim has authored numerous technical publications, book chapters and has spoken extensively, both domestic and internationally, in the compliance and quality areas. She is the editor of 2 well-known Stability books: the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She is also working on a manuscript for the textbook “Analytical Chemistry: An Introduction to Pharmaceutical GMP Laboratory,” that is expected to be available in 2019. Kim can be reached at kim.huynhba@pharmalytik.com.
  • Philip Jarvis, Global C&Q Lead, Abbvie

    Mr. Jarvis is an experienced team leader with over 20 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device / pharmaceutical / and biologics industries.
  • Steven Kuwahara, Principal Consultant, GXP BioTechnology, LLC

    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 Manager, Industry Expert

    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.
  • Kevin C. Martin, Marketing Partner Azzur, Azzur Group LLC

    Kevin Martin serves as Managing Partner, Azzur Group, LLC and General Manager, Azzur Group IT. Kevin has more than 40 years of FDA-regulated industry experience that includes management positions at Wyeth and McNeil Pharmaceutical. He is currently a General Manager for Azzur IT and a member of the Azzur Group Board of Directors. He was a member of the PhRMA Computer Systems Validation Sub-Committee (responding to the FDA’s issuance of the 1983 “Blue Book”), was the Core Team Secretary for the PDA Part 11 Task Group (working alongside FDA’s Paul Motise to develop industry guidance) and is a former Chair of the GAMP Americas and GAMP Global Steering Committees, and a contributor to several GAMP Good Practice Guides and Special Interest Groups.
  • James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA

    James Mason received his Doctor of Pharmacy degree in 2006 and then served as an officer in the U.S. Air Force. In 2009, he was Commissioned as an officer in the U.S. Public Health Service and began working for FDA as a Field Investigator (CSO) conducting domestic and international drug GMP inspections. In 2016, he became a Pharmaceutical Specialist and now serves as a Compliance Officer for the Office of Pharmaceutical Quality Operations in Parsippany, NJ, where his primary responsibility is handling violative pharmaceutical inspections for FDA regulatory actions. He is a Board Certified Sterile Compounding Pharmacist (BCSCP) and Pharmaceutical GMP professional (ASQ CPGP).
  • Chris Maughan, Managing Director, Thermal Compliance Ltd

    Chris is the Managing Director of Thermal Compliance Ltd, who specialize in the qualification of Thermal Systems. With over 15 years of hands-on validation experience in the Thermal and Biological Validation of Sterilization processes alongside temperature, humidity and CO2 mapping of Controlled Temperature Units. Chris has a detailed knowledge of validation systems and the use of wireless dataloggers, for the Qualification of Thermal Systems.
  • Patrick Mullin, Senior CQV/QAV Consultant, DPS Group Global

    Patrick Mullin has over 15 years of experience in vaccine and biotech operations which include commissioning, qualification, and validation (CQV) management for clinical and commercial scale biotech operations. Patrick's core focus is with the creation, implementation, and maintenance of CQV programs specializing in critical utilities, process equipment (upstream/downstream production and fill finish), process automated systems, and sterilization/cleaning support systems at pilot plant and full commercial scales.
  • Kim Munsell, Senior CSV & Compliance Manager, Janssen R&D

    Kim Munsell is from the Philadelphia area and has worked for Janssen R&D since 2007. She has a bachelor’s degree in biology from Eastern University and a master’s degree in pharmacology from Thomas Jefferson University. She started her career with a short stint as a Quality Control analyst in a GMP pharmaceutical manufacturing plant, and then worked as a protein biochemist and biologic inventory manager in a GLP Janssen BioTherapeutics laboratory for almost 11 years. In 2018, she joined the Lab Operations and Data Systems organization within Janssen BioTherapeutics and was recently promoted into the role of Sr Computer Validation & Compliance Manager. She is passionate about delivering streamlined operational processes and easy-to-use electronic systems that are in compliance with GLP, DDI, and CSV regulations.
  • Donnacha Nagle, Validation Lead, Eirchem Pharmaceuticals

    Donnacha Nagle is a pharmaceutical industry professional based in Ireland and is a recent graduate from the masters degree programme, MSc. in Pharmaceutical Validation Technology, at the Technological University Dublin (TU Dublin). Donnacha is an experienced Validation Engineer with over eleven years of experience in all areas of validation including; Process/Product Validation, Equipment/Automation Qualification, Facilities Qualification, Computer System Validation, Test Method Validation, and Cleaning Validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries. Donnacha has ambitions to become an industry leader within the pharmaceutical industry and is the current Chair of the BPCI Validation group, Ireland. Donnacha is also a recent winner of the 2018 Thesis award presented by KENX at their C&Q and Data Integrity conference, in Dublin, Ireland. Donnacha is also a published author with IVT/JVT, USA.
  • Dennis Plante, Senior Validation Market/Product Specialist, Amphenol / Kaye Instruments

    Dennis Plante is the Senior Validation Market/Product Specialist for Kaye instruments located in Billerica MA. With his engineering background and his 39 years with Kaye Intruments serving the Pharmaceutical and Biotech industry, Dennis has a deep understanding of the practical applications of Wired and Wireless technologies and their applications related to Thermal Validation.
  • Peju Odunusi, Owner, Pj Pharmceutical Consulting

    Dr. Peju Odunusi is an analytical R&D professional with over 25 years of experience in the pharmaceutical and medical device industries. She has extensive analytical and CMC expertise in product development from inception to launch, with emphasis on “doing it right” the first time. She has successfully established analytical and stability groups in the course of her career, participated in numerous audits and is very passionate about mentoring.
  • Roque, Redondo, VP Business Development Automation, Mirus Consulting Group Corp

    Mr. Roque Redondo has close to 30 years of experience including international experience in the validation, QA, engineering, compliance and regulatory affairs in the life science environment. He was part of the senior management team during the implementation of the remediation activities related to Schering-Plough Consent Decree. His experience includes Data Integrity, operations, serialization, validation, QA, engineering and technical services. Mr. Redondo has attended to over 10 different courses related to Data Integrity as well as he has written 5 articles related to this topic. He has a nice blend of experience, including process and cleaning procedures, that help him understand the importance of manufacturing operations without jeopardizing the quality of the products with strong management skills.
  • Lelia Scott, Executive Director, Global Quality Systems, Charles River Laboratories

    Ms. Scott is the Executive Director of the Global Quality Systems team at Charles River Laboratories. She has 15 years of progressively challenging QA experience within the pharmaceutical industry and 7 years in analytical lab sciences. She specializes in data integrity compliance, global process adoption, implementation of enterprise-wide quality systems, computer system validation, laboratory systems, relationship building in cross-functional teams and development of innovative solutions to expedite business processes using electronic systems in compliance with global pharmaceutical regulations. Ms. Scott holds a BSc in Chemistry from the University of Western Ontario and an MBA in Pharmaceutical Management from Fairleigh Dickinson University.
  • Ken Shitamoto, MS, Sr. Director IT, Gilead Sciences

    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.
  • J. Loren Smith, Senior Manager, Global Compliance & Ethics, Computer, BioMarin Pharmaceutical

    Loren has over 28 years of experience specializing in computer systems compliance (from the IT, QA, and Compliance perspectives) in medical device, biotech, pharmaceutical, analytical instrumentation, and software companies. Loren has also been an instructor at University of California, Berkeley, since 2006, teaching computer systems compliance to students in clinical research.
  • Ronald D. Snee, Founder and 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.
  • Raul Soto, Sr. Principal Software Engineer, Johnson & Johnson

    Raul Soto is a Senior Principal Software Engineer at Johnson & Johnson Vision Care (JJVC), focused on Computerized Systems Validation and Software Quality Engineering. Mr. Soto has over 20 years of experience in validation, process engineering, industrial automation, and software quality; and has held positions of increasing responsibilities in the medical devices, biotechnology, pharmaceutical, and consumer electronics industries. Raul has led multiple global and site projects in the United States, Europe and China. As an invited speaker he has lectured on computer systems validation, data integrity, statistics, PLC/SCADA automation, and quality/compliance issues at various conferences in the United States and Europe. Raul has an MS degree in Biotechnology with emphasis on Biomedical Engineering, and a BS degree in Mechanical Engineering. He is also an ASQ Certified Quality Engineer (CQE).
  • Abhijit Ray, CTO and Co-Founder, Aventior, Inc.

    Abhijit is the CTO and co-founder of Aventior. With over 20 years in technology and working with some of the leading Biotech and Pharma companies, Abhijit has been instrumental is designing new AI solutions for process automation including document processing. Aventior’s solutions for Continued Process Verification and Data Management helps Biotech firms help decrease their efforts in data management, meta-data management and compliance.
  • Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk

    Fred Ohsiek is the Sr Cleaning Validation Specialist and Cleaning Validation Work Package Owner for Novo Nordisk in Clayton, NC. He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. He was considered the cleaning validation subject matter expert in most positions held.
  • Thomas Miller, Senior Enterprise Architect, Azzur Technology Consulting Services

    As a Senior Enterprise Architect, Thomas (Tom) Miller serves as a trusted advisor and subject matter expert for our clients across a number of industries, including pharma/biotech, healthcare, and manufacturing. Tom joined Azzur Group from TUV OpenSky, where he led their Secure Cloud Enablement Practice and managed a team responsible for large-scale Enterprise transformation projects, such as merger & acquisitions work, data center consolidation, and cloud enablement. Tom specializes in assisting enterprises to move forward to cloud. Tom holds a Bachelor of Science in Computer Science from Drexel University in Philadelphia, PA.
  • Christopher Robitaille, Chief Technical Officer, Azzur Technology Consulting Services

    As Chief Technology Officer for Azzur Technology Consulting Services, Christopher (Chris) Robitaille is responsible for all technology projects the group delivers. Chris is a trusted advisor and subject matter expert for Azzur’s clients across a number of industries, including education, pharma/biotech, health, and manufacturing. With more than 30 years of experience, Chris is a trusted industry veteran. Before joining Azzur, he was the Director of Infrastructure Technology at a local college, managing a team of 14. He was responsible for large-scale IT transformation projects, such as data center forklift upgrades, cloud enablement, and migrations. Before that, he worked as a consultant on New York University’s Abu Dhabi campus data center project, as well as other enterprise endeavors at several Universities in the New York City area.
  • Jason Kelly, Vice President of Services, Lighthouse Worldwide Solutions

    Jason Kelly is Vice President of Services at Lighthouse Worldwide Solutions and is based in Oregon. He has over 20 years of experience in providing Monitoring Solutions to the Cleanroom Industry and specializes in Pharmaceutical, Medical Device, Life Science, Semiconductor, Aerospace and Military Cleanroom applications. Jason presents worldwide on current cGMP and Environmental Monitoring Systems from risk management, system design, GAMP protocols, system installation, validation, customer training and system service support.
  • David W. Vincent, CEO, MPH, PhD for VTI Life Science

    David Vincent has over thirty-two (32) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (20) twenty years dedicated to the field of validation (commissioning and qualification [C&Q]). He has B.Sc. degrees in industrial microbiology, B.Sc., Mechanical Engineering Technology, Master and PhD in Public Health. He has hands on experience in many areas of Regulatory Affairs, Quality Assurance and Commission/Qualification, Engineering including; regulatory submission preparation, Design Review, Microbiology Laboratory setup and qualification, Construction Qualification, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. He is especially strong in the areas of Process Development and Validation, Cleanroom design and management as well as developing and implementing Aseptic and Environmental Monitoring Programs. Most of his career has been in the Biological vaccine industries but also support medical devices, biotechnology and pharmaceutical industries
  • Steven Thompson, Director Industry Solutions, VALGENESIS

    Steve has worked in Life Sciences for over 20 years, has a Bachelor of Science degree in Computer Information Systems, served in both technical and quality roles. He’s a PDA certified auditor, has audited hundreds of companies globally, is a published author, and frequent speaker at conferences. Currently he’s Director of Industry Solutions for ValGenesis, Inc. (valgenesis.com)
  • Chinmoy Roy, Senior Industry Consultant, VALGENESIS

    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.
  • Tara Scherder, Partner, SynoloStats, LLC

    Tara has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the combination of statistics and process. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.
  • William T. Drummond Jr., Director, Global Computer Validation Quality Assurance, Charles River Laboratories

    William is currently the Director, Global Computer Validation Quality Assurance, at Charles River Laboratories. His responsibilities include managing and coordinating multi-business unit computer system validation (CSV) projects, quality assurance (QA) oversight of corporate IT, data integrity improvement, training, vendor audits, and internal audits. Besides his current role, he has worked in the biopharma industry since 2000 as a systems integrator and a CSV and QA consultant. He is a retired U.S. Army Lieutenant Colonel whose career included positions with various field artillery units and computer systems development project management offices. He has a Master of Science in Computer Science, concentrating in Artificial Intelligence, from the U.S. Naval Postgraduate School and a Bachelor of Science from the U.S. Military Academy at West Point, NY.
  • Shelley Preslar President, Azzur Training Center

    Shelley serves as President of the newly established Azzur Training Center (ATC) in Raleigh, NC, where she leads a team dedicated to providing comprehensive and customizable cGMP training. Prior to founding ATC, Shelley was the managing partner of Azzur Group Raleigh, which she opened in 2014 and built to a team of 30 specializing in consulting services across the product lifecycle in life sciences. Shelley has more than 20 years of FDA-regulated industry experience that includes time spent in both operating companies and consulting companies. She currently serves in several positions with PDA including being an Interest Group Leader, a member in Meeting Planning Committees, and co-chair on two technical documents related to aseptic processing and isolator design prepared to publish in 2020. Shelley holds a BS in Marine Biology from the University of North Carolina at Wilmington and an MBA in Global Management from the University of Phoenix. She is also a proud veteran of the U.S. Army and U.S. Marine Corps.

Sponsors


  • A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive.
    Website: https://www.azzur.com/
  • Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens.
    Website: https://www.ellab.com/

  • Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there.
    Website: https://commissioningagents.com
  • For almost sixty years, Kaye has been at the forefront of high accuracy process measurement. For applications from thermal process validation and environmental monitoring, to sensor calibration, Kaye technology has provided the most accurate and user friendly measuring systems available in the market today.
    Website: https://www.kayeinstruments.com/en/

  • Aventior (www.aventior.ai) is an AI and Data Science company that is building data management and process automation solutions for the life sciences industry. Its CPV Automation (“CPV Auto”) platform uses AI-assisted technologies to process batch records that are either printed, scanned or hand-written. Through this automation, Aventior has reduced document processing times by over 75%. Some of the leading biotech firms use this platform to reduce their dependency on manual effort, decrease their data collection efforts, reduce errors and reduce the time to stay FDA compliant.
    Website: www.aventior.ai
  • 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/
  • Founded in 1982, Lighthouse Worldwide Solutions is the world’s leading manufacturer and supplier of real-time air, liquid, gas and microbial contamination monitoring systems and particle counters. Our company has leveraged superior software design, data integration ability and worldwide support offices to provide our customers with leading edge environmental monitoring solutions. These solutions have positioned Lighthouse’s customers to enhance their risk mitigation and regulatory compliance systems and procedures, as well as to help ensure the high level of quality control required to increase product yields through continuously monitoring conditions that may have an adverse impact on their products.
    Website: http://www.golighthouse.com/
  • Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation.
    Website: https://ntint.com/
  • PharmaLex is one of the largest providers of Quality and Validation Services, Regulatory Affairs, Development Consulting and Pharmacovigilance & Risk Management worldwide. Our teams of experts offer a comprehensive portfolio of regulatory compliance services to support pharmaceutical, biopharmaceutical, and medical device organizations throughout the entire product lifecycle.
    Website: https://www.pharmalex.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

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Venue

Details

Start:
August 24
End:
August 26
Event Category:

Venue

Wyndham Philadelphia Historic District
400 Arch Street
Philadelphia, PA 19106 United States
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Phone:
(215) 923-8660
Website:
https://book.passkey.com/event/50086521/owner/16417/home

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