PROCESS VALIDATION &
CONTINUED VERIFICATION

AGENDA

12:00:00
Conference Registration

Coffee & Tea



13:15:00
Chairperson’s Opening Remarks



13:30:00
FDA Insight – Agency Updates and Compliance Trends

James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA



14:00:00
Optimize Your Validation Efforts Using Quality Risk Management

Lelia Scott, Executive Director, Global Quality Systems, Charles River Laboratories



14:30:00
Accelerate Process Validation with Data-Based Quality by Design

Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC



15:00:00
Networking Refreshment Break



15:30:00
Lean Validation – Ensure Quality While Reducing Cost

Phil Jarvis, Global C&Q lead for EU, Abbvie



16:00:00
Build a Streamlined Audit Trail Review Process

Matthew LaPierre, Data Integrity Specialist, Industry Expert



16:30:00
Examining Validation Training Effectiveness

Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin Pharmaceutical



17:15:00
Networking & Welcome Reception



7:00 am
Coffee and Lite Breakfast



7:30 - 8:15
Select Between Knowledge Exchange Sessions (1-4)



1
Change Control in Validation – Managing Like-for-Like Changes

Donnacha Nagle; Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals



2
Validation Risk Assessment – Develop a Practical and Pragmatic Program

Roque Redondo, VP Automation & Business Development, Mirus Consulting Group



3
Risk-Based Equipment Qualification

Chip Bennett, Assistant Director, Global C&Q, CAI



4
Detecting the Lack of Data Integrity

Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC



8:30 – 10:00
Select Between Knowledge Exchange Sessions (5-8)



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



10:00 am
Mid-Morning Refreshment Break



10:30 - 12:00 pm
Select Between Knowledge Exchange Sessions (9-12)



9
Implement a Risk-Based Process Validation Program Enterprise-wide

Phil Jarvis, Global C&Q lead for EU, Abbvie



10
Validation Statistics with Confidence and The Arts of Charts

Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC



11
A Cost Effective and Practical Approach to Risk-Based CSV

Michael Brunner, Computer Systems Validation Specialist, Upsher-Smith Laboratories, Inc.



12
Homo Sapiens atque Integritas Notitia, Expanded Edition – Human Beings and Data Integrity

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



12:00 pm
Grab & Go Lunch & Learns (13-16)



13
Analytical Methods Validation for QA and Validation Professionals

Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP



14
Right Size Sampling and Statistics for PPQ

Katherine Giacoletti, Partner, SynoloStats



15
Documentation Requirements for Successful Validation

Alan Golden, MS, Principal, Design Quality Consultants, LLC



16
Navigate the Maze of Data Integrity Regulations

Roque Redondo, VP Automation & Business Development, Mirus Consulting Group



1:15 - 2:45pm
Select Between Knowledge Exchange Breakfasts (17-20)



17
Risk-based Approaches to IQ/OQ/PQ Project Management

Patrick Mullin, Senior CQV, QAV Account Manager, DPS Global



18
Single Use Systems (SUSs) – Implementation and Validation

Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology



19
Implement a Data Infrastructure for Advanced Analytics

Eric S. Collier, Assistant Director, Automation and IT, CAI



20
Data Integrity Risk Assessment Across the Data Lifecycle

Chinmoy Roy, Senior Industry Consultant, VALGENESIS



2:45 pm
Afternoon Refreshment Break



3:00 - 4:45 pm
Select Between Knowledge Exchange Sessions (21-24)



21
Risk-Based Critical Cleaning Process Parameter and Critical Quality Attributes – A Case Study

Phil Jarvis, Global C&Q lead for EU, Abbvie



22
Environmental Monitoring and HVAC System Validation

Gamal Amer, Ph.D. Principal, Premier Compliance Services



23
Statistics for Risk Management Across the Product Lifecycle

Katherine Giacoletti, Partner, SynoloStats



24
Validation of Mobile Applications

Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care



4:45 pm
Day Two Closing Session



07:00 am
Coffee and Lite Breakfast



7:30 - 8:15 am
Select Between Knowledge Exchange Sessions (25-28)



25
Qualify Utilities – Water Systems, Clean Steam and Process Gases

Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology



26
Batch Record Process Automation Using AI for BioPharma

Abhijit Ray, Chief Digital Architect, Aventior, Inc.



27
Data Integrity Audit Preparation – Before and After

Peju Odunusi, Ph.D., Stability Group Leader, Abbott



8:30 – 10:00 am
Select Between Knowledge Exchange Sessions (29-32)



29
Conduct Risk-Based Revalidations and Periodic Reviews of Systems

Donnacha Nagle; Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals



30
Autoclave Validation - Periodic Benchmark Testing

Chris Maughan, Managing Director and Autoclave SME, Thermal Compliance Ltd



31
Conduct a Site-Wide Validation Gap Assessment

Connie Hetzler, Global Head – Validation, Alcon Laboratories



32
Overcome the Top Challenges of Data Integrity Implementation

Matthew LaPierre, Data Integrity Specialist, Industry Expert



10:00 am
Mid-Morning Refreshment Break



10:30 – 12:00 pm
Select Between Knowledge Exchange Sessions (33-36)



33
Cleaning Validation – Documents, SOPs and Strategies

Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk



34
Equipment Calibration – Measurements, Documentation and Project Management

TBD, Ellab



35
Medical Device Validation & Verification Master Class

Alan Golden, Senior CSV and Compliance Manager, Design Quality Consultants, LLC



36
Conduct a Gap Analysis of Computer Systems and Data Integrity

Patrick Mullin, Senior CQV, QAV Account Manager, DPS Global



12:00 pm
Grab & Go Lunch & Learns (37-39)



37
Creating an Effective Supplier Quality Agreement

Gamal Amer, Ph.D. Principal, Premier Compliance Services



38
Current Trends in Cleanroom Validation

Steve Thompson, Director Industry Solutions, VALGENESIS, Inc.



39
Transition from Paper to Electronic Validation – Overcome the Challenges

Kim Munsell, Sr Computer Systems Validation & Compliance Manager, Janssen R&D



1:00 - 2:30
Select Between Knowledge Exchange Sessions (40-42)



41
Streamline CSV Processes Across Multiple Sites and Cultures

Lelia Scott, Executive Director, Global Quality Systems, Charles River Laboratories



42
Construct and Analyze Validation Control Charts

Anthony Chikere, Senior Manager, Bayer Pharmaceutical



43
Create a Validation Strategy for Intelligent Automation

Steve Thompson, Director Industry Solutions, VALGENESIS, Inc.



2:30 pm
Afternoon Refreshment Break



2:45 - 4:15 pm
Select Between Knowledge Exchange Sessions (43-44)



44
Key Considerations for Process Validation and Successful Tech Transfer

David W. Vincent, Ph.D., CEO, VTI Life Sciences



45
Validating GXP Spreadsheets

Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care



4:30 pm
Close of Conference



SPONSORS



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Azzur Group

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/
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Ellab

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/




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CAI

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
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Kaye

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/




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Aventior

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
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CIMINFO Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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H&A Scientific

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/
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Lighthouse Worldwide Solutions

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/
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Novatek International

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/
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PharmaLex

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/
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QACV

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/

Process Validation & Continued Process Verification (CPV)


Process Validation is the backbone of all validation and is always under FDA regulatory scrutiny. KENX is excited to announce the definitive process validation and continued process verification conference of 2019. This event gives you the tools and technology needed to create, deploy and maintain best practices through all three stages of validation. Come to Philadelphia this spring and align with 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 in process validation
  • 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.

Pricing & Registration

For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.