CLEANROOM VALIDATION, DISINFECTION
AND ENVIRONMENTAL MONITORING
CLEANING UNIVERSITY: VIRTUAL CONFERENCE
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 2020. 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
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 fall. 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
& DATA INTEGRITY COMPLIANCE CONGRESS
AGENDA
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
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.
& DATA INTEGRITY COMPLIANCE CONGRESS
135 E Kings Highway
3rd Floor
Haddonfield, NJ 08033
Email: info@kenx.org
Phone: 858 649 3251