LABORATORY DATA INTEGRITY
COMPLIANCE CONGRESS
Recent FDA Warning Letters Highlight Laboratory Data Integrity Deficiencies
Most data integrity non-compliance are cited in the GMP laboratory. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures.
Choose From Over 20 Tutorials Addressing Today’s Top Analytical Challenges
Laboratory Data Integrity Compliance Congress Highlights Include:
- Develop, Implement and Maintain Data Integrity Protocols in the GMP Lab
- Conduct a GAP Analysis and Identify Root Causes
- Conduct an Laboratory DI Audit Enterprise-Wide
- Ensure the Reliability and Completeness of Analytical Data
- Discover the Impact of Human Behavior
- Implement Risk Management Protocols, Perform Assessments and Continually Verify
- Prepare for and Handle FDA DI Investigations
- Understand Requirements and Handle Audit Trail Reviews
Maximize Your Training! This Event is Co-located with Analytical Procedures and Methods Validation:
- Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
- Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
- Define and Develop the Content and Scope of Analytical Procedures Program
- Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
- Develop a Roadmap for Analytical Methods Validation
- Evaluate Characteristics through Statistical Analysis of Validation Data
- Development and Validation of a Stability-Indicating Analytical Method
- Learn How to Perform Risk-Based Evaluations
- Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
- Handle the FDA Laboratory Methods Verification Process
- Effectively Manage Transfer Studies and Protocols
Personnel in the Following Environments Should Attend:
- Validation
- QA/QC
- Scientist
- Chemist
- Laboratory Management
- Regulatory Affairs
- Data Integrity
This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.
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.
COMPLIANCE CONGRESS
STABILITY TESTING &
PROGRAM MANAGEMENT
Stability Testing & Program Management Excellence
Stability testing is critical to the efficacy of medical products. ICH, FDA and WHO stability guidance’s have been around for quite some time and are rigorously enforced, however, industry still has challenges to overcome and seeks more direction. The time has never been more critical to evaluate your program and ensure your organization has advanced, compliant processes that exceed the expectations of regulators.
Stability Leaders Discuss the Critical Elements of a Successful Program
KENX-PSDG Stability Track Topics
- Stability Stakeholders
- Inventory Systems
- Monitoring Systems
- Vaccines/Biologics/Gene Therapies Stability
- Stability Budgeting
- Stability Data Integrity
- Photostability
- Extractables & Leachables
- Innovative Labeling
- Stability Protocols
- Top 10 Stability 483s
- Stability Training
- Reference Standards Stability
- Stability Windows
- Shipping Studies
- Stability Automation
- Equivalence Studies
- Devices/Combination Products
- Clinical Supplies Stability
- Stability Review Boards
- Validating & Operating Stability Chambers
- Stability Statistics & Reports
- Laboratory Information Management Systems
- Best Practices in using Contract Stability Organizations
- International Stability Regulations
- Sample Handling
Personnel in the Following Environments Should Attend:
- Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device
- QA/QC
- Stability Laboratories
- Raw Materials
- Laboratory Management
- Regulatory Affairs
- Formulation
This event is also appropriate to business development and sales managers that offer innovative solutions for QC testing laboratories, data collection, and statistics.
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.
ANALYTICAL PROCEDURES &
METHODS VALIDATION
Analytical Procedures & Methods Validation
The time has never been greater to stay up-to-speed with current regulatory thinking. Between FDA’s interest in releasing guidance’s the last few years on Analytical Procedures & Methods Validation, Bioanalytical Methods Validation and a flurry of global regulations on data integrity, it is critical for you and your company to receive the training you need and avoid regulatory action. FDA, ICH and USP all recognize Analytical Development and Validation as top priority in the drug development process and each have respective guidance, albeit interpretation is left to industry. Not only does this event take a deep dive into how companies comply with regulations, but also showcases how leading companies develop methods, validate procedures and generate data and information that lead to critical business decisions. This conference takes participants through a best practice journey through the development, validation and transfer of analytical methods.
Choose From Over 25 Tutorials Addressing Today’s Top Analytical Challenges
Analytical Procedures and Methods Validation Highlights Include:
- Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
- Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
- Define and Develop the Content and Scope of Analytical Procedures Program
- Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
- Develop a Roadmap for Analytical Methods Validation
- Evaluate Characteristics through Statistical Analysis of Validation Data
- Development and Validation of a Stability-Indicating Analytical Method
- Learn How to Perform Risk-Based Evaluations
- Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
- Handle the FDA Laboratory Methods Verification Process
- Effectively Manage Transfer Studies and Protocols
Maximize Your Training! Laboratory Data Integrity Compliance Congress Highlights Include:
- Develop, Implement and Maintain Data Integrity Protocols in the GMP Lab
- Conduct a GAP Analysis and Identify Root Causes
- Conduct an Laboratory DI Audit Enterprise-Wide
- Ensure the Reliability and Completeness of Analytical Data
- Discover the Impact of Human Behavior
- Implement Risk Management Protocols, Perform Assessments and Continually Verify
- Prepare for and Handle FDA DI Investigations
- Understand Requirements and Handle Audit Trail Reviews
Personnel in the Following Environments Should Attend:
- Validation
- QA/QC
- Scientist
- Chemist
- Laboratory Management
- Regulatory Affairs
- Data Integrity
This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.
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.
LABORATORY UNIVERSITY
AGENDA
Laboratory University
Laboratory University contains 3 amazing events at one location! Create your own event by choosing from over 40 knowledge exchanges tutorials, including:
Analytical Procedures & Methods Validation
- Life Cycle Management and Training Implementation
- Risk-Based Test Method Validation
- Analytical Transfer and Comparability Studies
- Method Variation – Handling Measurement Uncertainty
- Stability-Indicating Analytical Methods
- Criteria for System Suitability Testing Limits
Stability Testing & Program Management
- Risk Management and Critical Quality Attributes
- Forced Degradation and Reduced Study Designs
- Program Development, Implementation and Management
- OOS and OOT Investigations for Analytical Testing
- In-Use and Excursions – Stability beyond ICH
- Process Capability, Stability and Control
Laboratory Data Integrity Compliance Congress
- Building a Program from the Ground Up
- Good Documentation Practices
- Human Error Reduction Strategies
- Risk Assessments – Using Process Flow Charts
- Quality Cultures that Identify and Address Risks
- Streamline Compliance Across Paper, Electronic and Hybrid Systems
…and so much more!
For more information on each of the 3 tracks, click here to be directed to their pages:
Analytical Procedures and Methods Validation
Stability Testing & Program Management
Laboratory Data Integrity Compliance Congress
Personnel in the Following Environments Should Attend:
- Validation
- QA/QC
- Scientist
- Chemist
- Laboratory Management
- Regulatory Affairs
- Data Integrity
This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.
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.
Faculty
CLEANROOM VALIDATION, DISINFECTION
AND ENVIRONMENTAL MONITORING
AGENDA
7:30 AM PDT
Exhibitor Showroom and Virtual Platform Open House
8:00 AM PDT
Chairperson’s Opening Remarks
8:15 AM - 8:45 AM PDT
EU GMP Annex 1 — The Impact on Cleaning and Disinfection
Jim Polarine Jr., MA., Senior Technical Service Manager, STERIS Corporation
8:45 AM - 9:15 AM PDT
A Roadmap to ISPE Cleaning Validation and PDA TR 49 Biotechnology Guides
Beth Kroeger, Technical Services Manager, STERIS Life Sciences
9:15 AM - 9:45 AM PDT
Microbial Control — 5 Things You Need to Know
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
9:50 AM - 10:20 AM PDT
Exhibitor Showroom and Think Tank Sessions
10:30 AM - 11:00 AM PDT
Know the Impact and Reduce Risk
Dawn Marshall, Senior Director Global Quality, Sanofi Pasteur
11:00 AM - 11:30 AM PDT
Operational Readiness — Fast Track to Vertical Start Up
Charlie Maher, Global Director, Process and Manufacturing Technology, CAI
11:30 AM - 12:00 PM PDT
Qualification of Visual Inspection — Introduction to the ASTM E3263 Standard Practice
Andrew Walsh, MS, CLSSBB President, Center for Pharmaceutical Cleaning Innovation
12:30 PM - 1:15 PM PDT
Select Between Knowledge Exchange Sessions (1-3)
Cleanroom Disinfection — 5 Things You Need to Know
Beth Kroeger, Technical Services Manager, STERIS Life Sciences
Investigations of Alert/Action Level Excursions
Elizabeth Brockson, Senior Validation Specialist, CAI
Common Gaps in Cleaning Validation and Their Solutions — From Pain to Optimization
TJ Woody, Director of Cleaning Validation, Azzur Group
1:30 PM - 2:00 PM PDT
Exhibitor Showroom and Think Tank Sessions
2:15 PM - 3:45 PM PDT
Select Between Knowledge Exchange Sessions (4-6)
Clean By Design — Successful Implementation of a Holistic, Riskbased Program for Cleanroom Design, Cleaning and Monitoring
Ravi Samavedam, President, Azzur Cleanrooms on Demand™
Commisssion and Qualification of Clean Utilities
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
Science, Risk and Statistics-based Cleaning Process Development and Validation — The Key Elements for Success
Andrew Walsh, MS, CLSSBB, President, Center for Pharmaceutical Cleaning Innovation
4:00 PM - 4:30 PM PDT
Exhibitor Showroom and Think Tank Sessions
4:45 PM - 6:15 PM PDT
Select Between Knowledge Exchange Sessions (7-9)
Design and Construction of Cleanrooms — Optimize Performance and Compliance
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
Design of an Environmental Montiroing Performance Qualification Program
Dawn Marshall, Senior Director Global Quality, Sanofi Pasteur
Establish Acceptance Criteria and Set Health Limits
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
6:15 PM - 7:00 PM PDT
Game Night - Trivia Welcome Reception
7:30 AM PDT
Exhibitor Showroom Opens
8:00 AM - 9:30 AM PDT
Select Between Knowledge Exchange Sessions (10-12)
Microbial Control — Develop a Proactive Approach to Reduce Risk
Elizabeth Brockson, Senior Validation Specialist, CAI
Analyze and Organize Trending Data
Erin Thane, Vice President, Azzur Labs
Discover Risk-based Approaches to Cleaning Monitoring and Manufacturing Equipment
Dawn Marshall, Senior Director Global Quality, Sanofi Pasteur
9:45 AM - 10:15 AM PDT
Exhibitor Showroom & Think Tank Sessions
10:30 AM - 12:00 PM PDT
Select Between Knowledge Exchange Sessions (13-15)
Development and Validation of Disinfectant Efficacy
Madison Hoal, Global Technical Consultant, Ecolab Life Sciences
Establish Sampling Sites and Execute Plans Based on Risk
Joscelyn Bowersock, Customer Success Manager, L7 Informatics
Validation of Analytical Methods Used in Cleaning
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
12:15 PM - 1:00 PM PDT
Select Between Knowledge Exchange Sessions (16-18)
Cleaning and Disinfection — Create a Training Strategy Playbook for Operaters
Jim Polarine Jr., MA., Senior Technical Service Manager, STERIS Corporation
Best Documentation Strategies for Critical Information
Joscelyn Bowersock, Customer Success Manager, L7 Informatics
Cleaning Process Development from Lab Bench to Full Scale — Lean Six Sigma Case Study
Ruijin Song, MS, Senior Cleaning Validation Scientist, Center for Pharmaceutical Cleaning Innovation
1:15 PM - 2:45 PM PDT
Select Between Knowledge Exchange Sessions (19-21)
Reduce Deviations and Contamination Events through Effective Training
Shelley Preslar, President, Azzur Training Group
Develop an Approach for Non-sterile Environments
Mihir Vashi, Validation Lead, Alcon (Invited)
Multi-Product Risk-Based Cleaning Validation – Build It from the Ground Up
Kenneth Pierce, Ph.D., Cleaning Validation & Development Specialist, Hyde Engineering + Consulting
3:00 PM - 3:30 PM PDT
Exhibitor Showroom & Think Tank Sessions
3:45 PM - 5:15 PM PDT
Select Between Knowledge Exchange Sessions (22-23)
Design a Monitoring System Contamination Control Strategy
Jason Kelly, Vice President of Services, Lighthouse Worldwide Solutions
Selection of Cleaning Agents and Parameters
Keith Bader, VP of Cleaning Science and Technical Services, Hyde Engineering + Consulting
CLEANING UNIVERSITY: HYBRID CONFERENCE
Attend Virtually or in San Diego, CA
May 11-12, 2021
Many companies spend 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 and disinfection, cleanroom design, environmental monitoring and cleaning validation practices at their facility. This hybrid conference showcases those paving the way in best practices in cleaning validation, cleanroom qualification, disinfection, contamination control, environmental monitoring and more. You have the opportunity to choose between 3 distinct tracks in Cleanroom Operations and Disinfection, Cleaning Validation and Critical Cleaning Processes, or Environmental Monitoring. You can also experience all 3 tracks by registering for our Cleaning Passport. This conference delivers more the 30 tutorials in:
Cleanroom Operations and Disinfection
- Design and construction – Optimize performance and compliance
- Implementation of a holistic, risk-based program
- Development and validation of disinfectant efficacy
- Create a playbook for operators
- Determine optimal sampling sited
- Create a risk-based culture and define roles and responsibilities
- Identify contamination risks and conduct an assessment
- Reduce validation timelines and cost
Cleaning Validation & Critical Cleaning Processes
- Establish acceptance criteria and set health limits
- Learn latest trends and overcome top challenges
- Discover risk-based approaches to cleaning monitoring and manufacturing
- Create a Cleaning Validation Master Plan – Key elements for success
- Validation of analytical methods used in cleaning
- Selection of cleaning agents and parameters
- Implement a personnel training program and gowning procedure
- Maintain stainless steel equipment in sterile environments
Environmental Monitoring
- Investigations of alert/action level excursions
- Trend data and analyze results
- Develop a robust, risk-based program from the ground Up
- Implement a continuous monitoring program
- Qualify water, clean steam and process gasses
- Establish sampling sites and execute plans based on risk
- Best documentation strategies for critical information
- Develop an approach for non-sterile environments
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.
PROCESS VALIDATION &
CONTINUED VERIFICATION
AGENDA
11:00 IST
Detecting the Lack of Data Integrity
12:00 IST
Chairperson’s Opening Remarks
12:15 - 13:15 IST
FDA Insight – Agency Updates and Compliance Trends
James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)
13:15 - 14:00 IST
Effective Risk-based Decision Making
Nuala Calnan, Ph.D., Founder & Principal, BioPharm Excel Ltd.; Adjunct Research Fellow, Technological University Dublin
14:00 IST
Exibitor Showroom and Think Tank Sessions
15:00 - 15:30 IST
Examine Validation Training Effectiveness
Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin
15:30 - 16:00 IST
Detecting the Lack of Data Integrity
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC
16:00 - 16:45 IST
FDA’s Proposed Computer Software Assurance Guidance
Kevin Martin, General Manager & Managing Partner, Azzur Group LLC, Senthil Gurumoorthi, Associate Director, and Ken Shitamoto, Senior Director, Gilead Sciences
16:45 IST
Game Night - Trivia Welcome Reception
8:00 IST
Exhibitor Showroom Opens
8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions (1-3)
Validation Audit Preparation
Phil Jarvis, Global C&Q lead for EU, AbbVie
Validation Case Study — Using Mixed Reality Technology in C&Q in Equipment and Systems
Donnacha Nagle; Validation Consultant & Academic Researcher, TU Dublin
Create an Effective Supplier Quality Agreement
Elizabeth Rivera, Technical Services Manager, STERIS
9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions (4-7)
Implement a Risk-Based Process Validation Programme
Phil Jarvis, Global C&Q lead for EU, AbbVie
Contamination Control Strategy – An Implementation Approach
Walid El Azab, Senior Manager Technical Services, STERIS
Personnel Training – Hiring People that Make Validation Great
Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex
Build a Change Control Programme from the Gound Up
Alma O’Reilly, Validation Manager, LEO Pharma Dublin
11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions
12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions (8-11)
Process Validation Statistics for Non-statisticians
Alan Golden, MS, Principal, Design Quality Consultants, LLC
Optimize Your Validation Efforts Using QRM
William T. Drummond Jr., MSCS, Senior Director, Global Quality Systems, Charles River Laboratories
Navigate the Maze of Data Integrity Regulations
Roque Redondo, VP Automation & Business Development, Mirus Consulting Group
Build Your Custom Audit Checklist – Master Class
Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
13:00 - 13:30 IST
Exhibitor Showroom and Think Tank Sessions
13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions (12-15)
Risk-Based Cleaning Validation – Key Elements for Success
Chip Bennett, Assistant Director, Global C&Q, CAI
lign Your CSV Programme with FDA’s Proposed CSA Guidance
Kevin Martin, Senior Director & Managing Partner, Azzur Group
Cultivate the Culture of Integrity in Data Management
Peju Odunusi, Ph.D., Owner, PJ Pharmaceutical Consulting LLC
Learn How to Use Statistics as a Risk Tool
Tara Scherder, Partner, and Katherine Giacoletti, Partner, SynoloStats
15:30 - 16:00 IST
Exhibitor Showroom and Think Tank Sessions
16:15 - 17:45 IST
Select Between Knowledge Exchange Sessions (16-19)
HANDS-FREE Validation Using Augmented Reality
Steve Thompson, Director Industry Solutions, ValGenesis, Inc.
Validation Statistics with Confidence and The Arts of Charts
Ronald D. Snee, Ph.D., President, Snee Associates, LLC
Manage Data Integrity Inspections and Respond to Findings
Peju Odunusi, Ph.D., Owner, PJ Pharmaceutical Consulting LLC
Mastering the Critical Elements of a QRM Programme
Roque Redondo, VP Automation & Business Development, Mirus Consulting Group
17:45 IST
Close of Day Two
8:00 IST
Exhibitor Showroom Opens
8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions (20-22)
The Big Reshuffle – Impact Assessment and System Criticality
Donnacha Nagle, Validation Consultant & Academic Researcher, TU Dublin; Laura Butchart, Validation Lead, ParagonV; Phil Jarvis, Global Commissioning & Qualification Lead (EU), AbbVie
Remote FAT Execution – Best Practices
Alice Redmond, Vice President European Operations, CAI
Inspection Management – Root Cause Analysis and Corrective Action (CAPA)
Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex
9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions (23-26)
Lean Validation - Ensure Quality While Reducing Costs
Phil Jarvis, Global C&Q lead for EU, AbbVie; Jerry Quirke, Lead Process Engineer, Kneat Solutions
Qualify Utilities — Water Systems, Clean Steam and Process Gases
David W. Vincent, Ph.D., CEO, VTI Life Sciences
Mapping CQA, CPP, CA – Methodology, Risk Assessment, Sustaining Operations and Change Control
Alice Redmond, Vice President European Operations, CAI
Conduct a Change Control Impact Assessment
Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions
11:45 - 12:45 IST
Select Between Knowledge Exchange Sessions (27-30)
Cleaning Validation – Documents, SOPs and Checklists
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
Medical Device Validation & Verification Master Class
Alan Golden, MS, Principal, Design Quality Consultants, LLC
Build a Streamlined Audit Trail Review Process
Matthew LaPierre, Data Integrity Specialist, Industry Expert
Integrate Risk Management into Change Control Processes
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
13:00 - 13:30 IST
Exhibitor Showroom and Think Tank Sessions
13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions (31-34)
Risk-Based Equipment Qualification
Chip Bennett, Assistant Director, Global C&Q, CAI
The Validation Master Plan (VMP) – Plans that Impress Investigators
Connie Hetzler, Global Head – Validation, Alcon Laboratories
Computer Software Assurance Master Class
Senthil Gurumoorthi, Associate Director and Ken Shitamoto, Senior Director, Gilead Sciences
Overcome the Top Challenges of Data Integrity Implementation
Matthew LaPierre, Data Integrity Specialist, Industry Expert
15:30 - 16:00 IST
Exhibitor Showroom and Think Tank Sessions
16:15 – 17:45 IST
Select Between Knowledge Exchange Sessions (35-38)
Process Validation and Successful Tech Transfer
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
Cleaning Validation – Documents, SOPs and Checklists
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
Right Size Sampling and Statistics for PPQ
Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats
Data Integrity Risk Assessment Across the Data Lifecycle
Valgenesis
17:45 IST
Close of Conference
Process Validation & Continued Process Verification (CPV)
Attend Virtually!
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 2021. This event gives you the tools and technology needed to create, deploy and maintain best practices through all three stages of validation. 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 special student pricing,
email lisa.benevento@kenx.org or
call 856-308-9777
Validation University
AGENDA
10:30 IST
Exhibitor Showroom and Virtual Platform Open House
11:00 IST
Chairman's Opening Remarks
11:15 - 12:30 IST
Effective Risk-based Decision Making
Nuala Calnan, Ph.D., Founder & Principal, BioPharm Excel Ltd.; Adjunct Research Fellow, Technological University Dublin
12:30 - 13:30 IST
FDA Insight – Agency Updates and Compliance Trends
James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)
13:15 IST
Exibitor Showroom and Think Tank Sessions
14:00 - 14:30 IST
Examine Validation Training Effectiveness
Danielle Duran, Senior Manager, Training and Development, Site Business Operations, BioMarin
14:30 - 15:15 IST
Detecting the Lack of Data Integrity
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC
15:30 IST
Exibitor Showroom and Think Tank Sessions
16:15 - 16:45
Assessing GxP SaaS Vendors – Maximize Application Utility, Performance and Compliance
Stephen R Ferrell CISA CRISC CDPSE – Managing Director, CompliancePath
16:45 - 17:30 IST
FDA’s Proposed Computer Software Assurance Guidance
Kevin Martin, General Manager & Managing Partner, Azzur Group LLC, Senthil Gurumoorthi, Director IT, and Ken Shitamoto, Senior Director, Gilead Sciences
17:30 IST
Game Night - Trivia Welcome Reception
8:00 IST
Exhibitor Showroom Opens
8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions
Validation Audit Preparation
Phil Jarvis, Global C&Q lead for EU, Abbvie
Benefits of Verification Activities Using Virtual Reality
Donnacha Nagle; Validation Consultant & Academic Researcher, TU Dublin
Create an Effective Supplier Quality Agreement
Elizabeth Rivera, Technical Services Manager, STERIS
9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions
Implement a Risk-Based Process Validation Programme
Phil Jarvis, Global C&Q lead for EU, Abbvie
Contamination Control Strategy – An Implementation Approach
Walid El Azab, Senior Manager Technical Services, STERIS (invited)
Personnel Training - Hiring People that Make Validation Great
Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex
Build a Change Control Programme from the Gound Up
Alma O’Reilly, Validation Manager, LEO Pharma; Researcher, Technological University Dublin
11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions
12:00 - 12:45 IST
Select Between Knowledge Exchange Sessions
Process Validation Statistics for Non-statisticians
Alan Golden, MS, Principal, Design Quality Consultants, LLC
Optimize Your Validation Efforts Using QRM
William T. Drummond Jr., MSCS, Senior Director, Global Quality Systems, Charles River Laboratories
Navigate the Maze of Data Integrity Regulations
Roque Redondo, VP Automation & Business Development, Mirus Consulting Group
Build Your Custom Audit Checklist – Master Class
Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
13:00 - 13:30 IST
Exhibitor Showroom and Think Tank Sessions
13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions
Risk-Based Cleaning Validation – Key Elements for Success
Chip Bennett, Assistant Director, Global C&Q, CAI
Align Your CSV Programme with FDA’s Proposed CSA Guidance
Kevin Martin, Senior Director & Managing Partner, Azzur Group
Cultivate the Culture of Integrity in Data Management
Peju Odunusi, Ph.D., Owner, PJ Pharmaceutical Consulting LLC
Learn How to Use Statistics as a Risk Tool
Tara Scherder, Partner, and Katherine Giacoletti, Partner, SynoloStats
15:30 - 16:00 IST
Exhibitor Showroom and Think Tank Sessions
16:15 - 17:45 IST
Select Between Knowledge Exchange Sessions
HANDS-FREE Validation Using Augmented Reality
Steve Thompson, Director Industry Solutions, ValGenesis, Inc.
Validation Statistics with Confidence and The Arts of Charts
Ronald D. Snee, Ph.D., President, Snee Associates, LLC
Manage Data Integrity Inspections and Respond to Findings
Peju Odunusi, Ph.D., Owner, PJ Pharmaceutical Consulting LLC
Mastering the Critical Elements of a QRM Programme
Chinmoy Roy, Senior Industry Consultant, Valgenesis
17:45 IST
Close of Day Two
8:00 IST
Exhibitor Showroom Opens
8:30 - 9:15 IST
Select Between Knowledge Exchange Sessions
The Big Reshuffle – Impact Assessment and System Criticality
Laura Butchart, Validation Engineer; Phil Jarvis, Global C&Q lead for EU, Abbvie, Donncadh Nagle, Researcher TU Dublin; Validation Lead, Eirchem Pharmaceuticals
Remote FAT Execution – Best Practices
Alice Redmond, Chief Strategy Officer, CAI
Inspection Management – Root Cause Analysis and Corrective Action (CAPA)
Gerardo Gomez, Ph.D., Director of Validation Services, PharmaLex
9:30 - 11:00 IST
Select Between Knowledge Exchange Sessions
Lean Validation - Ensure Quality While Reducing Costs
Phil Jarvis, Global C&Q lead for EU, Abbvie; Jerry Quirke, Lead Process Engineer, Kneat Solutions
Commission and Qualification of Clean Utilities
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
Mapping CQA, CPP, CA – Methodology, Risk Assessment, Sustaining Operations and Change Control
Alice Redmond, Chief Strategy Officer, CAI
Conduct a Change Control Impact Assessment
Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
11:15 - 11:45 IST
Exhibitor Showroom and Think Tank Sessions
11:45 - 12:45 IST
Select Between Knowledge Exchange Sessions
Cleaning Validation – Documents, SOPs and Checklists
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
Medical Device Validation & Verification Master Class
Alan Golden, MS, Principal, Design Quality Consultants, LLC
Build a Streamlined Audit Trail Review Process
Matthew LaPierre, Data Integrity Specialist, Industry Expert
Integrate Risk Management into Change Control Processes
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
13:00 - 13:30
Exhibitor Showroom and Think Tank Sessions
Matthew LaPierre, Data Integrity Specialist, Industry Expert
13:45 - 15:15 IST
Select Between Knowledge Exchange Sessions
Risk-Based Equipment Qualification
Chip Bennett, Assistant Director, Global C&Q, CAI
Use Continuous Monitoring to Reduce Periodic Review Resources
Connie Hetzler, Global Head – Validation, Alcon Laboratories
Computer Software Assurance Master Class
Senthil Gurumoorthi, Director IT and Ken Shitamoto, Senior Director, Gilead Sciences
Overcome the Top Challenges of Data Integrity Implementation
Matthew LaPierre, Data Integrity Specialist, Industry Expert
15:30 - 16:00 IST
Exhibitor Showroom and Think Tank Sessions
16:15 – 17:45
Select Between Knowledge Exchange Sessions
Process Validation and Successful Tech Transfer
David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
Create Validation Strategy for Intelligent Automation
Steve Thompson, Director Industry Solutions, ValGenesis, Inc.
Right Size Sampling and Statistics for PPQ
Tara Scherder, Partner and Katherine Giacoletti, Partner, SynoloStats
Data Integrity Risk Assessment Across the Data Lifecycle
Chinmoy Roy, Senior Industry Consultant, VALGENESIS
17:45 IST
Close of Conference
VALIDATION UNIVERSITY COMES TO DUBLIN – VIRTUALLY!
Attend Virtually!
Knowledge Exchange Network (KENX) is very excited to announce their Validation University is returning virtually to Ireland this summer. 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 50 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.
50 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe
Commissioning & Qualification
- Implement a Risk-based Verification Strategy
- Harness Product and Process Knowledge to Drive a Risk-based IQ, OQ, and PQ Approach
- Manage a Large CQV Project as Part of a Tech Transfer to an Existing Facility
- Qualify Temperature Mapping and Storage Chambers
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 Revalidations and Periodic Reviews of Validated Systems
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
- Master the Key Components to Build and Maintain an Inspection-proof Program
- Discover a GDPR Compliant Approach for SAAS, IAAS, and Other Software Services
- Develop an IT Infrastructure and Network Qualification Roadmap
Data Integrity Compliance
- Construct a Program from the Ground Up
- Prepare for and Perform a Data Integrity Audit
- See Remediation Projects and How to Build for the Future
- Know How to Respond to Data Integrity Inspection Findings
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.
Pricing & Registration
For special student pricing,
email lisa.benevento@kenx.org or
call 856-308-9777
Faculty
CSV & Data Integrity Compliance Congress Returns to Dublin Virtually!
Attend Virtually!
MHRA, FDA and many other global regulations have issued many guidance’s regarding Data Integrity. How does one navigate this maze? Moreover, as data integrity matures and malicious threats have become commonplace, what do you do next? How do you manage your entire DI and Computer Systems Validation programs; governance, human errors, cloud computing, network infrastructures, auditing, and identifying and responding to gaps? The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. KENX is pleased to announce that our comprehensive CSV& DI Congress is returning virtually to Ireland and showcases the protocols, methodology, and actions necessary to avoid regulatory action.
Choose From Over 20 Tutorials Addressing Today’s Top Challenges
Computer System Validation
- Cybersecurity – Addressing Malicious Threats to the Life Science Industry
- Master the Key Components to Build and Maintain an Inspection-proof Program
- Discover a GDPR Compliant Approach for SAAS, IAAS, and Other Software Services
- Develop an IT Infrastructure and Network Qualification Roadmap
Data Integrity Compliance
- Construct a Program from the Ground Up
- Prepare for and Perform a Data Integrity Audit
- See Remediation Projects and How to Build for the Future
- Know How to Respond to Data Integrity Inspection Findings
AND MUCH MORE!
Personnel in the Following Environments Should Attend:
- Validation
- Quality Assurance
- Engineering
- IT
- Quality Control
- Manufacturing Management
- Laboratory Management
- Regulatory Affairs
This event is also appropriate for business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection, and statistics.
Pricing & Registration