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Archive for category: Conferences

You are here: Home1 / Conferences
Conferences

LABORATORY DATA INTEGRITY
COMPLIANCE CONGRESS

LABORATORY DATA INTEGRITY
COMPLIANCE CONGRESS

AGENDA

SPONSORS

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite



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.

February 24, 2021/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2021/02/KENX-07.jpg 1035 1693 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2021-02-24 15:47:192021-03-12 16:00:29LABORATORY DATA INTEGRITY
COMPLIANCE CONGRESS
Conferences

STABILITY TESTING & PROGRAM MANAGEMENT

STABILITY TESTING &
PROGRAM MANAGEMENT

AGENDA

SPONSORS

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite



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.

February 24, 2021/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2021/02/KENX-06.jpg 1035 1693 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2021-02-24 15:23:232021-03-11 22:14:15STABILITY TESTING & PROGRAM MANAGEMENT
Conferences

ANALYTICAL PROCEDURES & METHODS VALIDATION

ANALYTICAL PROCEDURES &
METHODS VALIDATION

AGENDA

SPONSORS

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite



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.

February 24, 2021/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2021/02/KENX-05.jpg 1035 1693 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2021-02-24 14:29:012021-03-12 15:51:02ANALYTICAL PROCEDURES & METHODS VALIDATION
Conferences

LABORATORY UNIVERSITY

LABORATORY UNIVERSITY

AGENDA

SPONSORS



July 23, 2020

Azzur Group





July 23, 2020

CAI

July 23, 2020

Novatek International





July 23, 2020

H&A Scientific

July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

April 13, 2021

Zifo RnD Solutions

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite


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

February 22, 2021/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2021/02/KENX-04-3.jpg 1035 1693 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2021-02-22 19:27:272021-03-19 17:08:13LABORATORY UNIVERSITY
Conferences

CLEANING UNIVERSITY

CLEANROOM VALIDATION, DISINFECTION
AND ENVIRONMENTAL MONITORING

AGENDA

  • Day One: May 11th, 2021
  • Day Two: May 12th, 2021
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



SPONSORS



July 23, 2020

Azzur Group

July 23, 2020

CAI





July 23, 2020

Novatek International





July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

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

Register for Track

  • 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

Register for Track

  • 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

Register for Track

  • 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

 

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite



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


All 20 /Cleaning University Speakers 20

Beth Kroeger

Charlie Maher

Cynthia Duhigg

David W. Vincent

Dawn Marshall

Elizabeth Brockson

Erin Thane

Fred Ohsiek

Jason Kelly

Jim Polarine Jr.

Joscelyn Bowersock

Keith Bader

Kenneth Pierce

Madison Hoal

Mihir Vashi

Ravi Samavedam

Ruijin Song

TJ Woody

Shelley Preslar

Andrew Walsh

November 10, 2020/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2021/02/KENX-01-5.jpg 1035 1693 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2020-11-10 20:49:252021-03-19 14:56:34CLEANING UNIVERSITY
Conferences

PROCESS VALIDATION & CONTINUED PROCESS VERIFICATION

PROCESS VALIDATION &
CONTINUED VERIFICATION

AGENDA

  • Day 1 - June 28th, 2021
  • Day 2, June 29th, 2021
  • Day 3, June 30th, 2021
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



SPONSORS



July 23, 2020

CAI





October 15, 2020

CompliancePath

July 23, 2020

Kaye

November 9, 2020

Validify





July 23, 2020

CIMCON Software

September 3, 2020

Kneat

July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite



For special student pricing,

email lisa.benevento@kenx.org or

call 856-308-9777

July 13, 2020/by rculver
https://kenx.org/wp-content/uploads/2020/07/KENX-03-2.jpg 1035 1693 rculver https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png rculver2020-07-13 06:06:252021-04-12 14:00:16PROCESS VALIDATION & CONTINUED PROCESS VERIFICATION
Conferences

VALIDATION & GMP UNIVERSITY EUROPE

Validation University

AGENDA

  • Day One - June 28th, 2021
  • Day Two - June 29th, 2021
  • Day Three - June 30th, 2021
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





SPONSORS



July 23, 2020

CAI





October 15, 2020

CompliancePath

July 23, 2020

Kaye

November 9, 2020

Validify





July 23, 2020

CIMCON Software

September 3, 2020

Kneat

July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite



For special student pricing,

email lisa.benevento@kenx.org or

call 856-308-9777

Faculty


Alan M Golden

Alice Redmond

Chinmoy Roy

Chip Bennett

Connie Hetzler

Danielle Duran

David W. Vincent

Dawn Marshall

Elizabeth Rivera

Fred Ohsiek

Gerardo Gomez

Ido Raz

James Mason

Jerry Quirke

Katherine Giacoletti

Ken Shitamoto

Kenneth Pierce

Kevin Martin

Laura Butchart

Matthew LaPierre

Nuala Calnan

Peju Odunusi

Philip Jarvis

Raul Soto

Ronald D. Snee

Roque Redondo

Senthil Gurumoorthi

Stephen Ferrell

Steven Thompson

Tara Scherder

William T. Drummond Jr.

Donnacha J. Nagle

July 13, 2020/by rculver
https://kenx.org/wp-content/uploads/2020/07/KENX-02-4.jpg 1035 1693 rculver https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png rculver2020-07-13 06:04:262021-04-12 13:56:25VALIDATION & GMP UNIVERSITY EUROPE
Conferences

COMPUTER SYSTEMS VALIDATION
& DATA INTEGRITY INSPECTION READINESS

Sponsorship Inquiry

AGENDA

SPONSORS



July 23, 2020

CAI





October 15, 2020

CompliancePath

July 23, 2020

Kaye

November 9, 2020

Validify





July 23, 2020

CIMCON Software

September 3, 2020

Kneat

July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite



For special student pricing,

email lisa.benevento@kenx.org or

call 856-308-9777

July 13, 2020/by rculver
https://kenx.org/wp-content/uploads/2020/07/KENX-01-4.jpg 1035 1693 rculver https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png rculver2020-07-13 06:01:452021-04-12 13:58:44COMPUTER SYSTEMS VALIDATION
& DATA INTEGRITY INSPECTION READINESS

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