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Commissioning, Qualification & VALIDATION UNIVERSITY

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Facilities * Equipment * Process * CSV * Cleaning * Data Governance

February 26 - February 28

San Diego, United States

CQV University Lands in San Diego!

 

Knowledge Exchange Network (KENX) is very excited to announce Validation University is going to be held in California this winter! The event is a dream come true for engineering, quality, validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and FDA-regulated industries. Participants create their own experience by choosing from over 44 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.  We look forward to seeing you at the amazing Bahia Resort Hotel!

 

44 Tutorials Overflowing with Rich Content and Tangible Takeaways for the Validation Universe

 

Commissioning & Qualification

  • Implement a Lean, Risk-Based Verification Approach for C&Q
  • Conduct Compliant Utility Qualification for HVAC, Water and Gas
  • Develop a Risk Management Program that Defines Requirements and Drives Qualification
  • Develop and Execute Storage Temperature Mapping Validations

 

Process Validation

  • Discover Lessons Learned from an Initial Campaign
  • Implement a Compliant Continued Process Verification (CPV) Program
  • Use CAPA for Nonconformance and Positive/Improved Outcomes
  • Leverage Technical Transfer and Engineering Studies

 

Cleaning Validation

  • Take a Deep Dive into Each Phase of Validation
  • Define Critical Cleaning Process Parameters and Attributes (CPP and CPA)
  • Establish Acceptance Criteria and Set Residue Limits
  • Develop a Process Performance Qualification (PPQ) Protocol Strategy

 

Computer System Validation

  • Master A Life Cycle Approach and Implement Enterprise-Wide
  • Implement and Operate Infrastructure Design and Automated Systems
  • Perform a Part 11 Gap Assessment
  • Implement Validation Protocols for Excel™ Spreadsheets

 

Data Integrity Compliance

  • Ensure Governance Throughout the Life Cycle
  • Learn how to Conduct Risk Assessments and Investigate Root Causes
  • Prepare for and Handle Investigators in a Regulatory Audit
  • Implement DI by Design of Manufacturing Automation Systems

 

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 to business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the lifescience environment.

Agenda

  • 1:00
    Chairperson’s Opening Remarks
  • 1:15
    Current FDA CQV Regulatory Trends and Warning Letters, and How to Prepare for the FDA Inspection Coming Soon to a Facility Near You
    JR Humbert, Head, Technical and Validation Standards, Genentech
  • 2:00
    Validation Cost Management – Watch the Bottom Line and ROI
    Connie Hetzler, Global Head of Validation, Alcon Laboratories
  • 2:30
    Lessons Learned from an Initial Process Validation Campaign
    Warren Kenzie, Manager Quality Engineering and Validation, Genentech
  • 3:30
    Leverage Technical Transfer and Engineering Studies in Process Validation
    Jorge A. Cordero, BSChE, BA-GM, Validation and Metrology Site Lead, Bausch + Lomb
  • 4:15
    Migration to Pharma 4.0 – What It Means to the Industry
    Chinmoy Roy, CSV and Data Integrity SME, retiree Genentech Inc.
  • 5:00
    Temple University RA/QA Masters Program Scholarship Award & Welcome Reception
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (1-4)
  • (1)
    Good Documentation Practices for a Process Validation Phased Approach
    Keiwanna Harris, Senior QA Validation Engineer, BioMerieux, Inc.
  • (2)
    Risk Management Tools for Validation
    David W. Vincent, CEO, VTI Life Sciences
  • (3)
    Effective Change Control Process for Facilities, Equipment and Computer Systems
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis
  • 08:30 – 12:00
    Select Between Execution and Master Planning Workshops (A-D)
  • (A)
    Walk Through a Process Validation Implementation Case Study
    David W. Vincent, CEO, VTI Life Sciences
  • (B)
    Lean Implementation of a Risk-Based Verification Approach for Commissioning & Qualification (C&Q)
    Philip Jarvis, Validation and QA Senior Manager, BioMarin
  • (C)
    Master A Life Cycle Approach for Computer Systems & Software Validation
    Thomas O’Brien, Validation Engineer, Bristol-Myers Squibb
  • (D)
    Data Integrity – Successful Implementation of Policy, Governance, Validation and Risk Management
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions (5-8)
  • (5)
    Quality by Design Considerations for Process Validation
    Naresh Desai, Senior Validation Manager, CSBio
  • (6)
    Device Validation and Verification – Risk-Based Decision Making for Each Path
    Connie Hetzler, Global Head of Validation, Alcon Laboratories
  • (7)
    Take a Deep-Dive into the Life Cycle Stages of Cleaning Validation – Key Elements to a Successful Program
    Ntoh Atem-Tambe, Scientist – Technical Services, G&W Laboratories
  • (8)
    Conduct a Part 11 Gap Assessment
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions (9-12)
  • (9)
    Establish a Compliant Continued Process Verification (CPV) Program Stage 3
    Philip Jarvis, Validation and QA Senior Manager, BioMarin Shanbally
  • (10)
    Develop a Risk Management Program that Defines System Requirements and Drives Subsequent Qualification
    Warren Kenzie, Quality Engineering and Validation Manager, Genentech, Inc.
  • (11)
    Qualification of Critical Utilities – HVAC, Water and Gas
    Rich Yeaton, President, Atlantic Technical and Validation Services
  • (12)
    Data Integrity by Design of Manufacturing Automation Systems
    Chinmoy Roy, CSV and Data Integrity SME, retiree Genentech Inc.
  • 07:30 – 08:15
    Select Between Knowledge Exchange Breakfasts (13-16)
  • (13)
    Overcome 5 Top Process Validation Challenges
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • (14)
    Develop a Sustainable IT Risk Management Procedure
    John Adams, Jr., Computer Systems Validation Lead, Spark Therapeutics, Inc.
  • (15)
    Perform Test Instrument and Systems Calibration Verifications
    Charles Cotter, Senior Validation Consultant, Sanofi
  • 08:30 – 10:00
    Select Between Knowledge Exchange Sessions (17-20)
  • (17)
    Implement a Statistics-based Approach for Process Validation
    To Be Announced
  • (18)
    The Validation Master Plan - What You Need to Know
    JR Humbert, Head Technical and Validation Standards, Genentech
  • (19)
    Cleaning Validation Documents Overview and Applications
    Fred Ohsiek, Senior Manager Cleaning Validation, Bayer
  • (20)
    Developing the Key Compliance Documents – User Requirements Specification (URS)
    Chinmoy Roy, CSV and Data Integrity SME, retiree Genentech Inc.
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (21-24)
  • (21)
    Using Design of Experiments (DoE) in Process Validation
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • (22)
    Advanced Professional Master Class
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • (23)
    Implement Validation Protocols for Excel™ Spreadsheets
    John Adams, Jr., Computer Systems Validation Lead, Spark Therapeutics, Inc.
  • (24)
    Equipment Qualification – Requalify Equipment, Systems, and Processes
    Jorge A. Cordero, BSChE, BA-GM, Validation and Metrology Site Lead, Bausch + Lomb
  • 1:00 – 2:30
    Select Between Knowledge Exchange Sessions (25-27)
  • (25)
    Using Quality System Elements to Maintain Your Process’ Validated State
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • (26)
    Temperature Mapping – Develop and Execute Storage Temperature Mapping Validations
    Jorge A. Cordero, BSChE, BA-GM, Validation and Metrology Site Lead, Bausch + Lomb
  • (27)
    Facility Qualification – Cleanroom Design and Environmental Monitoring
    David W. Vincent, CEO, VTI Life Sciences
  • 3:00 – 4:30
    Select Between Knowledge Exchange Sessions (28-30)
  • (29)
    CAPA for Validation Nonconformance and Positive/Improved Outcomes
    Debbie Yacob, Senior Principal Validation Engineer, Baxter Healthcare Corporation
  • (30)
    Establishing Acceptance Criteria for Cleaning Validation
    Fred Ohsiek, Senior Manager Cleaning Validation, Bayer Berkeley
  • (31)
    Decommissioning – The End of the Life Cycle – Do I have something to do Next?
    Charles Cotter, Senior Validation Consultant, Sanofi

Faculty

  • John Adams, Jr., Computer Systems Validation Lead, Spark Therapeutics, Inc.

    Mr. Adams is a seasoned Computer Systems Validation professional within 17 years of experience working in an FDA regulated environment. Using a risk-based approach, Mr. Adams has validated a wide range of computer system ranging from ERP, LIMS, record/document management, Environmental Monitoring Systems (EMS), Distributed Control Systems (DCS) for lyophilization processes, and blood banking software.
  • Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.

    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.
  • Ntoh Atem-Tambe, Scientist – Technical Services, G&W Laboratories

    Ntoh Atem-Tambe is a pharmaceutical professional and scientist with over 12 years of experience in the Active Pharmaceutical Ingredient (API) and finished product pharmaceutical industry specifically in the areas of: manufacturing and technical operations, quality and compliance, cleaning validation and risk assessment of manufactured pharmaceuticals. With a strong science background and problem-solving skills, Ntoh has been able to serve as a catalyst for profitable and organized change and improvement, managing multiple initiatives and projects in the pharmaceutical Industry.
  • Jorge A. Cordero, BSChE, BA-GM, Validation and Metrology Site Lead, 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.
  • 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.
  • Charles Cotter, Senior Validation Consultant, Sanofi

    Mr. Cotter is a graduate of Worcester Polytechnic Institute with a B.S. in Analytical Chemistry and an experienced resource with over twenty-seven years of experience in pharmaceutical and biopharmaceutical environments. He has held positions in different areas (chemistry, compliance, validation and consulting) and his areas of interest in validation include: utilities, facilities, analytical methods, equipment/automated processes, requalification and cleaning validations.
  • Naresh Desai, Senior Validation Manager, CSBio

    Mr. Desai is an energetic experienced modern leader with over 15 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, analytical instrument, equipment/automated processes, cleaning validation and shipping validation. Through strategic thinking, he has success in steering and managing complex validation projects within the biotech, medical device and pharmaceutical industries.
  • Keiwanna Harris, Senior QA Validation Engineer, BioMerieux, Inc.

    Keiwanna Harris is an experienced Senior Quality Assurance/Validation Engineer with extensive experience in engineering, validation, and quality in both pharmaceutical and medical device environments. Validation experience includes CTU equipment, sterilization, computer validation, process validation, requalification, and cleaning validation.
  • 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.
  • JR Humbert, Head, Technical and Validation Standards, Genentech

    Mr. Humbert is an experienced team leader with over fifteen years of experience in all areas of validation including: cleaning validation, process/product validation, equipment/facilities/utilities qualification, process automation, CSV and 21 CFR Part 11, and analytical test method validation. He has worked as a consultant for both pharmaceutical and biotechnology companies, and has also worked in validation/quality assurance in API, biologics, finished product, and medical devices facilities worldwide.
  • Philip Jarvis, Validation and QA Senior Manager, BioMarin

    Mr. Jarvis 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. His accomplishments also expands into a successful start-up biotech facility with the world’s largest perfusion process.
  • Warren Kenzie, Manager Quality Engineering and Validation, Genentech

    Warren Kenzie was the Quality Lead for the start-up of a highly automated cell culture plant (8x25k liter production bioreactors). As the Quality Engineering Manager, Warren supports the design phase of capital projects and works closely with the validation organization to define the testing strategy. Warren has both participated and led the implementation of two separate risk management programs.
  • Carmen Medina, MPH, PhD(c), VP Techinical Services, PAREXEL International, Former FDA Investigator

    Carmen-Medina-SME-Spotlight
    Ms. Medina uses over 30 years of FDA experience to support an array of international clients in their preparations for successful Pre-approval, GMP, GCP and combo-device inspections. She was a former Commissioned Officer in the United States Public Health Service and a PAI Investigator with the FDA, where she led an international group within Team Biologics and helped usher in the new medical device QSR regulations. Over the past 28 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands and bio-generics. See her textbook on Amazon: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics.
  • Thomas O'Brien, Validation Engineer, Bristol-Myers Squibb

    Mr. O’Brien received his BSc. in BioChemistry and Chemistry from University College Dublin Ireland. His career includes positions that has given extensive knowledge throughout the validation and GMP environments, including; Senior Manufacturing Technologist (Ispen), Quality Control Analyst (Wyeth Medica/Pfizer), Validation Lead (GSK), Senior Validation Engineer (Sanofi) and Computer Systems Validation Engineer (BMS).
  • Fred Ohsiek, Senior Manager Cleaning Validation, Bayer

    Fred Ohsiek, is the senior manager of Cleaning Validation and site cleaning validation SME for Bayer U.S. LLC, located in Berkeley CA. He earned his BS 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 18 years of cleaning validation while working at various pharmaceutical companies. He has been considered the cleaning validation subject matter expert in most of the positions held.
  • Chinmoy Roy, CSV and Data Integrity SME, retiree Genentech Inc.

    Chinmoy Roy is a seasoned life sciences professional with over 38 years of industry experience. Mr. Roy’s extensive implementation experience in engineering, CSV, data integrity and IT compliance provides the foundation for my consulting and training services. While at Genentech, he was the principal technical lead for several engineering teams. These teams were engaged in the design, commissioning, validation and obtaining USFDA certification for IT and manufacturing IT systems for two paperless biologics manufacturing facilities totaling over a billion dollars. These systems were compliant with 21 CFR Part 11, and ISA’s S88 and S95 standards.
  • Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems

    Mr. Soto is an experienced leader with over 25 years of experience in quality and all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, analytical method validation, equipment/automated processes and cleaning validation. Mr. is currently Director Client Engagement & Product Strategy, ValGenesis Systems.
  • David W. Vincent, 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.
  • Rich Yeaton, President, Atlantic Technical and Validation Services

    Rich Yeaton has over twenty five years’ experience working in FDA regulated industries. He was initially introduced to GMP operations on the devices side as a development engineer in DuPont’s medical products division, where he developed and improved new process equipment, and then was told to validate what he had designed. He moved on to help start Phoenix Imperative, an engineering and validation consulting company serving the biopharm industry. A key achievement with Phoenix was leading validation teams at two MedImmune cell culture facilities to assist them to obtain their first two commercial licenses.
  • Tara Scherder

    Tara Scherder has over 30 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.
  • Lou Killian, Director Customer Education, Kneat Software

    Lou Killian has extensive LifeScience leadership experience in Quality, Operations, Engineering Services, Regulatory, Business Systems with Abbott, Genentech, BioMarin. Lou’s passion is applying technology to meet business process needs. His current role is Director Customer Education & Success with Kneat Software.
  • Richard A. Mineo, Vice President, Encova

    Richard A. Mineo is a Licensed Professional Engineer with a Master of Science in Mechanical Engineering and has been working in the Biotechnology, Pharmaceutical and Medical Device Industry for more than 24 years. He has held senior leadership roles in commissioning and validation on multiple large green field projects as well as established global manufacturing organizations in the United States and Europe. Recently, he used his passion for process improvement to implement a successful global software solution for a major Biotechnology company that resulted in a 50% reduction in CQV cycle times and reduced personnel hours.

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Venue

Details

Start:
February 26
End:
February 28
Event Category:
Website:
https://www.kenx.org/events/validation-university-san-diego/

Venue

The Bahia Resort Hotel
998 W Mission Bay Dr
San Diego, CA 92109 United States
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Phone:
(858) 488-0551
Website:
http://bahiahotel.com/

Pricing & Registration

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