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VALIDATION UNIVERSITY

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

March 25 - March 27

Philadelphia, United States



VALIDATION UNIVERSITY HEADS TO PHILADELPHIA!

Knowledge Exchange Network (KENX) is very excited to announce Validation University is heading 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

  • Cybersecurity – Addressing Malicious Threats to the Life Science Industry
  • 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

 

Click Here to View the Agenda-At-A-Glance

 

Agenda

  • 12:00
    Conference Registration
    Coffee & Lite Snacks On-the-Go
  • 1:00
    1:00 Chairperson’s Opening Remarks
  • 1:15
    Breaking News - FDA Releases Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry
    Chris Wubbolt, Principal, QACV Consulting, LLC
  • 2:00
    Tips on Handling Data Integrity and Validation Inspections – An FDA Perspective
    Karyn M. Campbell, Director, Investigations Branch II, Division of Pharmaceutical Quality Operations, U.S. Food and Drug Administration (FDA)
  • 2:30
    Staying Ahead of the Validation and GMP Regulatory Curve through Warning Letter Knowledge
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories
  • 3:00
    Afternoon Networking Refreshment Break
  • 3:30
    Overcome the Top Five Validation Challenges
    Connie Hetzler, Global Head of Validation, Alcon Laboratories
  • 4:15
    A Systematic Approach for a Knowledge Management Model
    Robert J. Wherry, Head – R&D Data Systems QA & Compliance, Takeda
  • 5:00
    Temple University Scholarship Award & Welcome Reception
  • Close of Day One
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Select Between Knowledge Exchange Sessions (1-4)
  • (1)
    Documentation Requirements for Successful Validation
    Gamal Amer, Ph.D. Principal, Premier Compliance Services
  • (2)
    Qualification of Water Systems, Clean Steam Systems & Process Gasses
    Patrick Mullin, Senior CQV/QAV Consultant, DPS Group Global
  • (3)
    Strategies to Move to Electronic Systems
    Lelia Scott, Senior Director Global Quality Systems, Charles River Laboratories
  • (4) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity – Navigating the Maze of Regulations
    Kevin Martin, Managing Partner, Azzur Group
  • 8:30-10:00
    Select Between Knowledge Exchange Sessions (5-8)
  • (5)
    Successful Implementation of a 3-Stage Process Validation Program
    Mehron Mirian, Senior Quality Manager, Molecular Templates
  • (6)
    Risk-Based Cleaning Validation – Key Elements to a Successful Program
    Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences
  • (7)
    Implementation of a Risk-based Verification Strategy for CQV
    Joscelyn Bowersock, Regulatory and Quality Manager, Carolina BioOncology Institute
  • (8) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Construction of a Data Integrity Program from the Ground Up
    Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30-12:00
    Select Between Knowledge Exchange Sessions (9-12)
  • (9)
    Introduction to Validation Statistics for Non-Statisticians
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • (10)
    Key Considerations for Process Validation and Successful Tech Transfer
    Philip Jarvis, Validation Site Lead, Alcon
  • (11)
    Implement a Risk-Based Computer Systems Validation Program
    Lizzandra Rivera, Associate Director, Enterprise – e-Systems, Alexion Pharmaceuticals
  • (12) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Human Performance and Data Integrity - Transforming the Culture
    Danny Hernandez, Associate Director Data Integrity, Bayer
  • 12:00
    Lunch & Learns, Select Between (13-16)
  • (13)
    Training Personnel in Validation Execution
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (14)
    Go Beyond Warning Letter Trends and Guidance Documents
    Michael de la Torre, CEO, FDAZilla
  • (15)
    Conduct Risk-Based Revalidations and Periodic Reviews of Systems
    Jorge A. Cordero, Principal Validation Engineer, Bausch + Lomb
  • (16) DATA INTEGRITY INSPECTION READINESS SUMMIT
    CyberSecurity – Protecting Data Against Malicious Threats
    To Be Announced
  • 1:15–2:45
    Select Between Knowledge Exchange Sessions (17-20)
  • (17)
    Risk-based IQ/OQ/PQ Development and Execution
    Jorge A. Cordero, BSChE, MBA-GM, Principal Validation Engineer, Bausch + Lomb
  • (18)
    Medical Device Process Validation Implementation Case Study
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • (19)
    Hiring the People Who Make Validation Great
    Patrick Mullin, Senior CQV/QAV Consultant, DPS Group Global
  • (20) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity Assessments – Moving Past Assessment to Implementation
    Lizzandra Rivera, Associate Director, Quality – IT, Alexion Pharmaceuticals
  • 2:45
    Afternoon Refreshment Break
  • 3:15– 4:45
    Select Between Knowledge Exchange Sessions (21-24)
  • (21)
    Apply Quality Risk Management (QRM) in Validation Processes
    Connie Hetzler, Global Head of Validation, Alcon Laboratories
  • (22)
    The Validation Master Plan (VMP) – Plans that Impress FDA Investigators
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • (23)
    Performance Qualification Versus Process Validation
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories
  • (24) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity – Remediation Projects and Building for the Future
    Alice Redmond, Vice President European Operations, Commissioning Agents Inc.
  • 4:45 Day Two Closing Session
    Considerations for Using Spreadsheets in a GxP Compliant Environment
    Sanjay Agrawal, President and CEO, CIMINFO Software
  • Close Of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30–8:15
    Select Between Knowledge Exchange Breakfasts (25-28)
  • (25)
    CQV Master Class – Benchmark with Your Peers
    Alice Redmond, Vice President European Operations, Commissioning Agents Inc.
  • (26)
    Managing Changes in Validation Processes
    Mehron Mirian, Senior Quality Manager, Molecular Templates
  • (27)
    Prepare for Validation Inspections and Respond to Findings
    Milan Kalinic, Validation Lead, Alexion Pharmaceuticals
  • (28) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity Risk Assessments – Using Process Flow Charts
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • 8:30–10:00
    Select Between Knowledge Exchange Sessions (29-32)
  • (29)
    Continued Process Verification (CPV) – Maintain the Validation State
    Philip Jarvis, Site Validation Lead, Alcon
  • (30)
    Network Infrastructure and Cloud Qualification
    Lelia Scott, Senior Director Global Quality Systems, Charles River Laboratories
  • (31)
    Machine Learning – Validation and Data Integrity Compliance
    Steve Thompson, Director Computer Quality Assurance, Science 37
  • (32) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Managing FDA DI Inspections and Responding to Inspectional Findings
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (33-36)
  • (33)
    Apply Quality Risk Management (QRM) in Equipment Qualification
    Patrick Mullin, Senior CQV/QAV Consultant, DPS Group Global
  • (34)
    Developing and Documenting Quality Test Scripts
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories
  • (35)
    Conduct a Part 11 Gap Assessment
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (36) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Real World Case Studies in Data Integrity Audits
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • 12:00
    Lunch & Learns, Select Between (37-40)
  • (37)
    Quality by Design in Process Validation
    Joscelyn Bowersock, and Quality and Regulatory Manager, Carolina BioOncology Institute
  • (38)
    Importance of the Quality Agreement in Managing Vendors
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • (39)
    Establish Cleaning Residue Limits and Acceptance Criteria
    Ravi Samavedam, General Manager, Azzur Group
  • (40)
    Automated Risk-Based Data Integrity Processes
    Steve Thompson, Director Computer Quality Assurance, Science 37
  • 1:15- 2:30
    Select Between Knowledge Exchange Sessions (41-43)
  • (41)
    Statistical Process Controls – Construct and Analyze Control Charts
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • (42)
    Qualification Strategies for Temperature Mapping & Storage Chambers
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • (43) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Audit Trail Reviews & Data Integrity Compliance
    Robert J. Wherry, MSc, MS, CPIP, Head – R&D Data Systems QA & Compliance, Takeda
  • 2:30
    Afternoon Refreshment Break
  • 3:00- 4:30
    Select Between Knowledge Exchange Sessions (44-46)
  • (44)
    Equipment Qualification – Fit for Intended Use
    Milan Kilanic, Validation Lead, Alexion Pharmaceuticals
  • (45)
    Using Quality System Elements to Maintain Your Process Validated State
    Gamal Amer, Ph.D. Principal, Premier Compliance Services
  • (46) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Using Validation Sampling Plans for Critical Decisions
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • 4:30
    Close of Conference

Faculty

  • Gamal Amer, Ph.D. 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.
  • Joscelyn Bowersock, Regulatory and Quality Manager, Carolina BioOncology Institute

    Ms. Joscelyn Bowersock is a Quality and Regulatory Manager with nineteen years of clinical and research experience; including process implementation and validation, risk mitigation protocols, facility commissioning, and master file development. Her experience has allowed her to successfully implement numerous quality systems, navigate IND submissions, FDA inspections and cell therapy program accreditations.
  • Jorge A. Cordero, BSChE, MBA-GM, Principal Validation Engineer, Bausch + Lomb

    Jorge A. Cordero has over nineteen (19) years of experience in the biotechnology, pharmaceutical, medical devices and municipality industries in the technical services and management areas, including validation, engineering specification, and equipment design specification. Currently, Jorge is working with Bausch + Lomb managing the validation and metrology departments.
  • Danny Hernandez, Associate Director, BioMarin

    Mr. Hernandez is an experienced leader with over 14 years of Biotech experience. His experience includes: Manufacturing, Operational Excellence, Human Performance and Data Integrity. Through his diverse experience, he is sharing an approach to shape the culture around Data Integrity and Human Performance.
  • 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.
  • Philip Jarvis, Site Validation Lead, Alcon

    Phil is an experienced team leader with over ten 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 and pharmaceutical industries.
  • Milan Kilanic, Validation Lead, Alexion Pharmaceuticals

    Milan Kalinic is Pharmaceutical professional specializing in Sterile Fill Finish and Solid Dosage manufacturing environment with more than 13 years of experience. Currently works as a Validation Lead at Alexion Pharmaceuticals. Previous position includes Validation Specialist at Hemofarm (Member of STADA Arzneimittel Group). Milan was responsible for Leading of cross functional CQV Teams and manufacturing equipment projects delivery within the Hemofarm Group such as: Start-up of the Syringes & Cartridges Manufacturing Site, Start-up of the Ampoules Manufacturing Site and Start-up of the Sterile Nasal Spray Manufacturing Site. Also, he was responsible for leading a Packaging Lines CQV team for start-up of Packaging Center for Solid Dosages Forms. Milan is manufacturing specialist for Filling Lines (CIP/SIP and Isolators), Compounding Systems, Autoclaves, Freeze Dryers, HVAC, Water Systems and Systems for Pharmaceutical Gases.
  • Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience

    Mr. LaPierre is an experienced data integrity project manager, successfully implementing an effective program at Ipsen Bioscience. He has a thorough understanding of not only the foundation and principles of data integrity but the project management tools and resources needed to execute a truly effective data integrity program at a pharmaceutical site. He is currently working to implement similar programs across global Ipsen.
  • Kevin Martin, Managing Partner, Azzur Group

    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.
  • Mehron Mirian, Senior Quality Manager, Molecular Templates

    Mehron Mirian has more than 18 years of experience in Quality and Engineering in the Medical Device, Pharmaceuticals, Biotechnology and Diagnostics industries. Mehron, who holds a BS in Biology, has worked for companies such as Cardinal Health, Bio-Rad, B.Braun, Avid, and Molecular Templates. Mehorn currently manages quality department in Molecular Templates as the Senior Quality Manager.
  • 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.
  • Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories

    Erik Muegge’s experience is focused on FDA and related regulated environments for pharmaceuticals, consumer products, and medical devices. His specific areas of work include Quality Systems, operations, outsourcing, process re-engineering, project management, product development life cycle (R&D through Launch) and validation. Erik has; led efforts in several PPC (Production and Process Controls) areas; harmonized validation activities globally across seven sites; audited quality systems of strategic partners; been recognized as a global SME resulting in three industry awards.
  • 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.
  • Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences

    Sunil has over 13 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors. Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry.
  • Alice Redmond, Vice President European Operations, Commissioning Agents Inc.

    Alice Redmond, PhD is Vice President, Europe Operations at Commissioning Agents, Inc. She has more than 28 years’ extensive experience in lifecycle management of pharma facilities inclusive of regulatory compliance, facility & process design, technology transfer, commissioning, qualification, and validation. Previously Ms. Redmond worked for 9 years for Sandoz/Novartis in Basel, Kundl and Ireland in the areas of quality, validation and technical operations. Following Novartis, Alice led the Global Regulatory, Commissioning and Qualification Group for a Global Engineering Company for 13 years. Alice has significant large global project experience of green field facilities including fill finish, biotech, gene therapy, medical devices, small and large molecule API and OSD from design through to operational readiness. She has presented projects internationally to numerous regulatory agencies and has facilitated many clients to PAI readiness or remediation. Alice regularly presents for ISPE, PDA and RAPS and was recently awarded a lifetime achievement award for PDA Europe. She is a former winner of the ISPE Robert F. Sherwood Article of the Year Award. She was a committee member on the Biotech and Disposables CoPs and Lead on the Knowledge Assets Committee. Alice currently serves on the ISPE C&Q CoP Steering Committee and is a former co-chair of this committee. She is on the ISPE Commissioning and Qualification Baseline® Guide Revision Team and serves as a training instructor in QRM for ISPE and collaborative ISPE and NIBRT training. Alice participated in the inaugural Women in Pharma forum at ISPE Annual Meeting 2016. Alice holds a PhD in Cell Culture from Dublin City University, an MBS in Project Management from University of Limerick and a Degree in Biotechnology from Dublin City University.
  • Lizzandra Rivera, Associate Director, Quality – IT, Alexion Pharmaceuticals

    Mrs. Rivera is a pharmaceutical professional with over 15 years of experience in validation and quality compliance. A Chemical Engineer graduate from the University of Puerto Rico, she has provided strategic leadership and tactical implementation guidance to establish a wide range of computerized systems and equipment, ensuring regulatory compliance is maintained throughout the systems’ lifecycles. She has a well-rounded background encompassing manufacturing, IT and quality assurance.
  • Chinmoy Roy, Data Integrity and CSV SME, Consultant, formerly Technical Team Lead, Genentech

    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.
  • Ravi Samavedam, General Manager, Azzur Group

  • Lelia Scott, Sr. Director Global Quality Systems, Charles River Laboratories

    Ms. Scott is a senior management quality professional with 14 years of progressively challenging QA experience within the pharmaceutical industry, and 7 years’ in analytical lab sciences. Her specializations include: global process adoption, implementation of enterprise-wide quality systems, global 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. She holds a Bachelor in Chemistry from the University of Western Ontario and an MBA in Pharmaceutical Management from Fairleigh Dickinson University
  • Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care

  • Steve Thompson, Director Computer Quality Assurance, Science 37

    Steve has over 20 years of GxP experience in Life Sciences (including Medical Device), is a Parenteral Drug Association (PDA) certified Auditor, has held managerial positions at various levels within Information Technology (IT) and Quality Assurance (QA) for major organizations, is a published author, and has presented at several conferences and industry associations. Steve has a B.S. in Computer Information Systems from DeVry University, City of Industry, California.
  • David W. Vincent, Ph.D., CEO, VTI Life Sciences

    Mr. Vincent has over 33 years’ experience in the health care industry specializing in the, biologic, biotechnology and biopharmaceutical industries and has over 25 years dedicated to the field of validation. Mr. Vincent has provided both project management and project execution for numerous clients national and international. He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.
  • Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Takeda

    Mr. Wherry has thirty-five (35) years of international pharmaceutical, biotechnology and medical device experience with expertise in Computerized System Validation, Data Integrity, Quality Systems, Process Validation, Aseptic Processing, Regulatory Operations and eCTD submissions. He has served as an industry consultant, performing data integrity audits around the globe at multiple companies. Bob currently is the Head of R&D Data Systems Quality Assurance and Compliance for Takeda, in Lexington, Massachusetts, and teaches part-time as an Adjunct Professor within the STEM Division's Biotechnology Program at Middlesex Community College in Massachusetts. Mr. Wherry has a Bachelor’s degree in Chemical Engineering from Lehigh University. He has a Master of Science, with distinction, from the University of Strathclyde (Glascow, UK) in Pharmaceutical Quality & GMP. He also has a Master of Science in Regulatory Affairs from Northeastern University. Bob also has certifications from ASQ and ISPE.
  • Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

    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.

Sponsors

  • GOLD




  • Manufacturer of complete Thermal Validation Solutions for food, pharmaceutical, medical and other industries
    Website: https://www.ellab.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/
  • FDAzilla, a subsidiary of Govzilla, is at the forefront of leveraging the power of Big Data and AI to make government data accessible, usable and valuable to everyone who needs it. Top Pharma Companies, Food Manufacturers, Medical Device Companies, and Service firms from around the globe rely on Govzilla to mine and process government inspection, enforcement, and registration data in order to quantify risk signals about their suppliers, identify market opportunities, benchmark against their peers, and to prepare for the latest inspection trends. Our data and analytics have been cited by major media outlets such as MSNBC, WSJ, and the Boston Globe. Our website, FDAzilla.com is viewed more than 1 million times per year. We are passionate about our mission to solve novel data and analytics problems for our customers. At Govzilla, we’re committed to our work, to our customers, and to having fun.
    Website: https://fdazilla.com/
  • 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/
  • We have expertise in the practical implementation of a wide range of statistical methodologies in all parts of the pharmaceutical product lifecycle.
    Website: https://www.synolostats.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

  • Temple University School Of Pharmacy

    RAQA: Combined, Defined, and Online. The Leader in Education RA and QA Professionals for 50 Years




    Website: http://www.temple.edu/pharmacy_qara
  • BioIT World

    Bio-IT World provides outstanding coverage of cutting-edge trends and technologies that impact the management and analysis of life sciences data, including next-generation sequencing, drug discovery, predictive and systems biology, informatics tools and personalized medicine.
    Website: http://www.bio-itworld.com/
  • Pharmaceutical Manufacturing

    Keen insights into the major manufacturing issues facing the industry today.
    Website: http://www.pharmamanufacturing.com

Venue

Details

Start:
March 25
End:
March 27
Event Category:

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

Pricing & Registration

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