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CLEANROOM VALIDATION, DISINFECTION AND ENVIRONMENTAL MONITORING

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February 17 - February 19

San Diego, United States

Many companies have spent an exorbitant amount of money and time on the qualification of cleanrooms and the validation of product manufactured within. KENX is proud to present a one-stop-shop for professionals tasked with the contamination control, cleanroom design and cleaning validation practices at their facility. This conference showcases those paving the way in best practices in cleaning validation, cleanroom qualification, disinfection, contamination control, environmental monitoring and more. This conference delivers more the 30 tutorials in:

 

Cleaning Validation & Critical Cleaning Processes

  • Implement a Risk-based Program
  • Set Acceptance Criteria and Health Limits
  • Determine Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)
  • Implement a Continuous Monitoring Program

 

Cleanroom Validation and Qualification

  • Ensure state of control through airflow quality
  • Determine what tests need to be performed
  • Implement IQ/OQ/PQ Protocols
  • See the latest aseptic technologies and best practice

 

Contamination Control & Disinfection

  • Understand the regulations and develop a strategy
  • Design a process for effective residue removal
  • Identify contamination risks and conduct an assessment
  • Reduce validation timelines and cost

 

Environmental Monitoring

  • Determine types of sampling performed and implement a strategy
  • Trend data and analyze results
  • Understand the key components a summary report
  • Monitor viable and non-viable particles

 

Agenda

  • 12:00
    Conference Registration
  • 1:00
    Chairperson's Opening Remarks
  • 1:15
    Cleanroom Specifications – Understand the Pending Impact of EU GMP Annex 1
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 1:55
    Stay Ahead of the Regulatory Curve – Cleaning Validation Inspections, Warning Letters and Trends
    Beth Kroeger, Technical Services Manager, STERIS Life Sciences
  • 2:35
    Microbial Control – Developing a Proactive Strategy to Reduce Risk
    Cindy Duhigg, Global Validation Steward, Alcon Laboratories
  • 3:15
    Networking Refreshment Break
  • 3:45
    Understand the Impact of Human Behavior in Sterile Environments
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 4:25
    Cleaning Validation Key Risk Assessment Areas and Dependencies
    Amy Bradford, Principal Consultant, CAI
  • 5:05
    Temple University Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 - 8:15
    Select Between Knowledge Exchange Sessions (1-2)
  • 1
    Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them Jim Polarine Jr., Senior Technical
    Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
  • 2
    Cleanrooms On Demand – A Paradigm Shift in Early Phase GMP Manufacturing
    Ravi Samavedam, President, Cleanrooms On Demand, Azzur Group LLC.
  • 8:30 - 10:00
    Select Between Execution and Master Planning Workshops (3-4)
  • 3
    Clean-by-Design – Develop a Risk-Based Approach to Contamination Control
    Cindy Duhigg, Global Validation Steward, Alcon
  • 4
    Risk-Based Cleaning Validation – Key Elements to a Successful Program
    Joscelyn Bowersock, Quality and Regulatory Manager, Carolina BioOncology Institute
  • 5
    Isolator Technology in Aseptic Processing – Design, Qualification and Maintenance
    Joe Cagnassola, Principal Validation Engineer, Alcon
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 - 12:00
    Select Between Execution and Master Planning Workshops (5-6)
  • 6
    Aseptic Processing – Key Technical and QA Requirements for Inspection-Readiness and Sustainable Commercialization
    Carmen Medina, MPH, Ph.D. (c), President, Precision Consultants, Inc.
  • 7
    Disinfectant Efficacy – Development and Validation
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 8
    Implement a Risk-Based, Compliant Cleaning Validation Management System
    Cheryl Zaman-Zadeh/Famili, MS, Director of Business Development and Sales, Novatek International
  • 12:00
    Networking Luncheon or Grab & Go Lunch & Learn (7-9)
  • 9
    Water, Clean Steam, and Process Gases – Qualification for Operational Excellence
    Cindy Duhigg, Global Validation Steward, Alcon Laboratories
  • 10
    Bench Scale Cleaning Studies – Development and Control of Processes Through Process Analytical Technologies (PAT)
    Keith Bader, VP of Cleaning Science and Technical Services, Hyde Engineering + Consulting
  • 1:15 - 2:45
    Select Between Knowledge Exchange Sessions (10-11)
  • 11
    Build an Effective Environmental Monitoring Program through a Well-Rounded Personnel Training Record
    Erin Thane, Vice President, Azzur Labs
  • 12
    Cleanroom Management and Operations
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 2:45
    Afternoon Refreshment Break
  • 3:15 - 4:45
    Select Between Knowledge Exchange Sessions (12-13)
  • 13
    Case Studies in Contamination Control
    Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
  • 14
    Establishing Acceptance Criteria for Cleaning Validation
    Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
  • 4:45
    Troubleshooting Tools for the CIP Practitioner
    Jeff Gaerke P.E., Principal Consultant Cleaning and Sterility, CAI
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 - 8:15
    Select Between Knowledge Exchange Breakfasts (14-15)
  • 15
    Create a Training Strategy Playbook for Operators in Cleaning and Disinfection
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 16
    Risk-Based Approaches in Cleaning Monitoring and Manufacturing Equipment
    Fred Ohsiek, Senior Specialist Cleaning Validation, Novo Nordisk
  • 8:30 - 10:00
    Select Between Knowledge Exchange Sessions (16-17)
  • 17
    Disinfectant Residues – Defining a Visual Standard
    Madison Hoal, Global Technical Consultant, Ecolab Life Sciences
  • 18
    Lifecycle Management of Analytical Methods for Cleaning Verification Support
    Mariann Neverovitch, Cleaning Validation SME, Bristol Myers Squibb
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 - 12:00
    Select Between Knowledge Exchange Sessions (18-19)
  • 19
    Visual Inspection – Implement a Risk and Science-Based Approach
    Igor Gorsky, Principal Consultant, Valsource, Inc.
  • 20
    HVAC – Qualify, Validate, and Maintain Using a Risk-Based Approach
    Joscelyn Bowersock, QA/RA Manager, Carolina BioOncology Institute
  • 12:00
    Grab & Go Lunch & Learn Sessions (21-22)
  • 21
    Environmental Monitoring System Design
    Jason Kelly, Vice President of Services, Lighthouse Worldwide Solutions
  • 22
    Contamination Control for Non-Sterile Environments
    Joscelyn Bowersock, Customer Success Manager, L7 Informatics
  • 1:15 - 2:45
    Select Between Knowledge Exchange Sessions (20-21)
  • 23
    Environmental Monitoring Data Trending and Analysis
    David Keen, Senior Global Microbiologist, Ecolab Life Sciences
  • 24
    Maintaining Your Stainless Steel Equipment in Sterile Environments
    Beth Kroeger, Technical Services Manager, STERIS Life Sciences
  • 2:30
    Afternoon Refreshment Break
  • 3:00 - 4:30
    Select Between Knowledge Exchange Sessions (22-23)
  • 25
    Validation of Disinfectant Efficacy Studies for Clean Room Environments
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 26
    Determine Optimal Sampling Sites in Cleanrooms
    Igor Gorsky, Senior Consultant, ValSource
  • 4:30
    Close of Conference

Faculty

  • Erin Thane, Vice President, Azzur Labs

    Erin Thane is the Vice President of Azzur Labs located in Allentown, PA. Starting out as a microbiologist working in a GMP contract testing lab, she has many years of experience working for various pharmaceutical clients at all stages of the EM program implementation. She has written various risk-based SOP’s, designed training programs and consulted with clients in setting up appropriate action plans for exceeded limits. Currently, she is focusing on helping Azzur Labs expand country-wide and enjoys the traveling opportunities this affords and the training of new colleagues.
  • 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
  • Beth Kroeger, Technical Services Manager, STERIS Life Sciences

    Beth Kroeger is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to process research cleaners, cleaning validation and critical environments and frequently speaks on these topics for the Institute of Validation Technology (IVT), United States Pharmacopeia (USP), International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and the National Institute for Bioprocessing Research and Training. Beth has over 25 year’s industry experience in R&D involving infectious diseases and Biopharmaceutical and Oral Solid Dose manufacturing operations. Prior to her current position, Beth was employed by Janssen Biologics and Biotest Pharmaceuticals where her areas of expertise included large scale fermentation systems, both continuous perfusion and fed batch, and downstream operations including large scale purification processing, viral removal, UF and final fill.
  • Jim Polarine Jr., MA. Senior Technical Service Manager, STERIS Corporation

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for sixteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.
  • Dawn Tavalsky, Senior Director of Global Quality, Sanofi

    Ms. Tavalsky is a Senior Director of Global Quality with Sanofi Pasteur, the vaccine division of Sanofi. She has over 30 years of experience in the pharmaceutical industry including small molecule, device, biologics and vaccines. She is a Sterility Assurance and Validation subject matter expert.
  • Keith Bader, VP of Cleaning Science and Technical Services, Hyde Engineering + Consulting

    Keith Bader earned a Bachelor of Science degree in Chemical Engineering from the University of Colorado at Boulder. He has worked at Hyde Engineering + Consulting for 20 years, and founded Hyde’s CORE Lab in 2011, a facility devoted to the development, exploration, and scaleup of cleaning processes for the pharmaceutical and biopharmaceutical industries. Keith has also published multiple journal and periodical articles as well as chapters in PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-by-Design by Duncan Lowe, and in Cleaning and Cleaning Validation, Volume 2, edited by Dr. Paul Pluta. Keith is currently an elected member of the Board of Directors for the Rocky Mountain Chapter of ISPE.
  • Fred Ohsiek, Sr Cleaning Validation Specialist and Cleaning Validation Work Package Owner, 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.
  • Cindy Duhigg, Global Validation Steward, Alcon Laboratories

    Cindy Duhigg has formal training in both microbiology and analytical chemistry, with 25 years’ experience in the pharmaceutical and medical device industries. She is an ASQ Certified Quality Auditor and Six Sigma Black Belt, with expertise in: • Validation project management, from design phase to continued process verification • Laboratory management, installation, and qualification • Particular expertise in cross-functional risk assessment and remediation
  • Ravi Samavedam, President, Azzur Cleanrooms on Demand LLC.

    Ravi has been with the company since 2012 and has around 20 years of experience in the biopharma industry. His area of expertise lies in phase-appropriate GMP implementation, validation, technology transfer, CMC and supplier management. Prior to Azzur, Ravi has held positions in Technical Operations, Validation and Quality organizations at Baxter, Amgen and Shire.
  • Igor Gorsky, Principal Consultant, Valsource, Inc.

    Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Principal Consultant at
  • Joscelyn Bowersock, MS-RA, Quality and Regulatory Manager, Carolina BioOncology Institute

    Ms. Joscelyn Bowersock is a Quality and Regulatory Manager with twenty 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.
  • Joe Cagnassola, Principal Validation Engineer, Alcon, Fort Worth, TX

    Mr Joe Cagnassola currently holds the position of Principal Validation Engineer with Alcon in Fort Worth, Texas. In this position, Joe participates in the validation of cleaning and sterilization equipment and processes. He is active in performing qualifications protocols, writing Master Plans and remediation and optimization efforts of process related activities. During his career, Joe has held validation position of increasing responsibility with DSM, Cardinal Health, Mallinckrodt and Patheon. Joe has professional interests in ASQ, he obtained his Certified Quality Engineer and Auditor Certifications and has been trained in Six Sigma and Lean.
  • Mariann Neverovitch, Research Scientist, Bristol-Myers Squibb

    Ms. Neverovitch is a Research Scientist at Bristol-Myers Squibb with 20+ years of experience in HPLC method development and validation for drug product, API and intermediates. She is a Cleaning Validation Subject Matter Expert with 15+ years of experience and is leading cleaning verification program in Support of Clinical Supply Operations. She is a Co-Author of ASTM WK15778 "Standard Guide For Science-based and Risk-based Cleaning Process Development and Validation" and number of articles for Cleaning Validation for the 21 Century series.
  • David Keen, Senior Global Microbiology Consultant, ECOLAB LIFE SCIENCES

    Specialties: Aseptic manufacturing utilising isolator technology. Isolator design and integration with novel manufacturing processes. Terminal sterilisation validation for sterile products. Medical device/pharmaceutical drug combinations. Pharmaceutical microbiology.
  • Madison Hoal, Global Technical Consultant, Ecolab Life Sciences

    Madison is a pharmaceutical microbiologist who has experience in the manufacture of a range of pharmaceutical formats including non-sterile liquids, topicals, and sterile injectables. Madison’s experience includes working with a team to design and qualify a clinical drug product manufacturing facility. She has experience developing an environmental monitoring program for an ISO classified aseptic manufacturing facility and established an on-site microbiology laboratory. She has also been responsible for site-wide aseptic operations training and gowning qualification programs.
  • Amy Bradford, Principal Consultant, CAI

    With more than 30 years’ experience in pharmaceutical and biotech manufacturing, Amy has worked as a microbiologist in manufacturing as well as laboratories. She has served as a subject matter expert in aseptic processes with a focus on cleaning programs, environmental monitoring and laboratory testing. Amy has supported manufacturing sites worldwide in the design, start-up, optimization, and troubleshooting of cleaning and environmental control programs.
  • Jeff Gaerke P.E., Principal Consultant Cleaning and Sterility, CAI

    With more than 30 years’ experience in biotech manufacturing, Jeff has worked as a process engineer in API manufacturing as well as formulation and filling. Serving as an engineering subject matter expert in with a focus on cleaning and sterilization, Jeff has supported manufacturing sites worldwide in the design, start-up, optimization, and troubleshooting of cleaning and sterilization processes.
  • Sheba Zaman B.S. in Computer Science Head of Product Specialists and Training Services Novatek International

    Sheba Zaman has been serving in a technical role at Novatek International for over 17 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade to establish procedures, work instructions, validation scripts and training program related to their data management systems.
  • 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.
  • Cheryl Zaman-Zadeh, Director Business Development Novatek International

    Cheryl Zaman Zadeh, MS. is the Director of Business Development & Sales at Novatek International where she has been for 20 years. She has played a key role in assisting many small and large organizations define their user requirements in order to fully automate their Environmental Monitoring process. She has experience in applying solutions to the Pharmaceutical, Medical Device, BioTechnology and Food Industry in the area of root cause analysis, the application of process improvement by virtue of continuous feedback loops, compliance, statistical analysis and risk based management.
  • Dave Manku Managing Partner, Azzur Group

    Dave is a Managing Partner for Azzur Group responsible for quality and technical direction for the company. Responsible for the daily operations, oversight of projects and personnel, staffing and business development to ensure continued success of business. Dave has extensive experience in pharmaceutical manufacturing, engineering, plant expansions and all phases of validation. Experienced in the design, construction and start up (inception through routine operation) of cGMP compliant facilities for the manufacture of pharmaceutical including the development of quality systems, commissioning/validation, and process design/optimization.

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/
  • 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

  • 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/

  • 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/
  • STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control.

    Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs.

    With offices located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world.
    Website: https://www.steris.com/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

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

    Website: http://www.temple.edu/pharmacy_qara

Partners

    More Information To Follow Soon

Venue

Details

Start:
February 17
End:
February 19
Event Category:

Venue

The Dana on Mission Bay
1710 W Mission Bay Dr
San Diego, CA 92109 United States
+ Google Map
Phone:
(619) 222-6440
Website:
https://www.thedana.com/‎

Pricing & Registration

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