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PROCESS VALIDATION & Continued Process Verification

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Master Planning * Risk * Statistics * Change Control * Documentation * CPV

February 26 - February 28

San Diego, United States

Process Validation & Continued Process Verification (CPV)

 

Process Validation is a critical part of  GMPs, a FDA regulatory requirement and one of the top issues cited in Warning Letters. KENX is excited to announce the definitive process validation conference of 2018. Our event gives you the tools and technology to start, implement and elevate your process validation program. Come to beautiful San Diego in February and witness best-in-class case studies that impress FDA investigators and make an immediate impact for your organization and professional career.

 

Top 10 Reasons to Attend:

  • Walk through a risk-based implementation case study
  • Master the Validation Master Plan (VMP)
  • Establish a compliant Continued Process Verification (CPV) process
  • Uncover the top 5 challenges
  • Leverage technology transfer and engineering studies
  • Discover a Quality by Design (QbD) approach
  • Process Performance Qualification (PPQ) – Select the optimal sampling plan
  • Develop a gap analysis checklist for your program
  • Understand how to use statistics
  • Learn an effective approach for combination products

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

 

This event is also appropriate to business development and sales managers that offer innovative solutions for change control, risk management, statistics and validation.

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
  • 4:30
    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 (1-2)
  • (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
  • 08:30 – 12:00
    3-Hour Knowledge Exchange Workshop
  • (A)
    Walk Through a Process Validation Implementation Case Study
    David W. Vincent, CEO, VTI Life Sciences
  • 1:15 – 2:45
    Select Between Knowledge Exchange Sessions (3-4)
  • (3)
    Quality by Design Considerations for Process Validation
    Naresh Desai, Senior Validation Manager, CSBio
  • (4)
    Device Validation and Verification – Risk-Based Decision Making for Each Path
    Connie Hetzler, Global Head of Validation, Alcon Laboratories
  • 3:15 – 4:45
    Select Between Knowledge Exchange Sessions (5-6)
  • (5)
    Establish a Compliant Continued Process Verification (CPV) Program Stage 3
    Philip Jarvis, Validation and QA Senior Manager, BioMarin Shanbally
  • (6)
    Develop a Risk Management Program that Defines System Requirements and Drives Subsequent Qualification
    Warren Kenzie, Quality Engineering and Validation Manager, Genentech, Inc.
  • 07:30 – 08:15
    Knowledge Exchange Breakfast
  • (7)
    Overcome 5 Top Process Validation Challenges
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • 08:30 – 10:00
    Select Between Knowledge Exchange Sessions (9-10)
  • (9)
    Implement a Statistics-based Approach for Process Validation
    To Be Announced
  • (10)
    The Validation Master Plan - What You Need to Know
    JR Humbert, Head Technical and Validation Standards, Genentech
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (11-12)
  • (11)
    Using Design of Experiments (DoE) in Process Validation
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • (12)
    Advanced Professional Master Class
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • 1:00 – 2:30
    90-Minute Knowledge Exchange Session
  • (13)
    Using Quality System Elements to Maintain Your Process’ Validated State
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • 3:00 – 4:30
    Select Between Knowledge Exchange Sessions (28-30)
  • (14)
    CAPA for Validation Nonconformance and Positive/Improved Outcomes
    Debbie Yacob, Senior Principal Validation Engineer, Baxter Healthcare Corporation

Faculty

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Tara Scherder, Partner, SynoloStats LLC

    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.
  • 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.

Sponsors

Partners

Venue

Details

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

Venue

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

Pricing & Registration

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