LABORATORY UNIVERSITY
AGENDA
11:00 PDT
Exhibitor Showroom and Virtual Platform Open House
12:30 PDT
Chairperson’s Opening Remarks
Analytical & Data Integrity Sessions
USP 1220: A Compendial Perspective
Leonel M. Santos, LMS Consulting, Formerly, Analytical Chemist, Senior Compendial Liaison, and Director of Chemical Medicines at U.S. Pharmacopeia
Lifecycle Management of Analytical Procedure and Methods Validation – FDA Perspective
Peju Odunusi, Ph.D., Owner, Pj Pharmaceutical Consulting
Use QbD and DoE Approaches to Produce Robust Methods
Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
Stability Sessions
Critical Elements for Stability Program Success
Chris Latoz, Stability Manager, Hollister Incorporated
Audit Preparation and Risk Assessments
John O’Neill, Editor, StabilityHub
Overcome the Challenges of Stability Studies with Combination Products
Geoff Carr, Ph.D., Director, Analytical Development, Patheon, part of Thermo Fisher Scientific
2:30 - 3:00 PDT
Exhibitor Showroom and Think Tank Sessions
Analytical & Data Integrity Sessions
Data Integrity in the QC Lab — Warning Letters and Trends
Robert J. Wherry, MSc, MS –Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals
Ensure Analytical Procedures and Methods are Fit for Purpose when Data Integrity is Essential
Heather Longden, Snr Marketing Manager and Isabelle VuTrieu, Pharmaceutical Market Development Manager, Waters Corporation
Data Integrity in the Lab – Common Issues and Solutions
Sanjay Agrawal, President and CEO, CIMCON Software
Stability Sessions
The Impact of Excursions and In-Use Conditions
Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
The COVID Accelerator Story: Formulation Development to Clinical Manufacturing in Two Months
Libby Russell, PhD, Senior Vice President, Neva Analytics
Shelf-Life Modeling using ASAP (Accelerated Stability Assessment Program)
Kenneth C. Waterman, Ph.D., President, FreeThink Technologies, Inc.
5:00-6:00 PDT
Game Night - Trivia Welcome Reception
7:00 PDT
Exhibitor Showroom Opens
7:15 - 8:00 PDT
Select Between Knowledge Exchange Sessions
Analytical
Implementation of cGMP Training – For the QC Scientist
Maria E. Orpilla, Senior Associate, Quality CMC, Nevakar Inc.
Data Integrity
Data Integrity Compliance Principles
Sheba Zaman, Head of Product Specialists and Training Services, Novatek
Stability
Application of Chemistry to Ensure Forced Degradation Studies are Effective
Geoff Carr, Ph.D., Director, Analytical Development, Patheon, part of Thermo Fisher Scientific
8:15–9:45 PDT
Select Between Knowledge Exchange Sessions
Analytical
Life Cycle Management of Analytical Procedures – A Roadmap
Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP
Data Integrity
The Critical Data Integrity Factor — Human Behavior
Matthew LaPierre, Data Integrity Specialist
Stability
Program Development, Implementation and Maintenance
Emily S. D. Trubee, MS, Stability Manager, Adare Pharmaceuticals
10:00 -10:30 PDT
Exhibitor Showroom and Think Tank Sessions
10:45 – 12:15 PDT
Select Between Knowledge Exchange Sessions
Analytical
Test Method Validation — Risk Assessments and Mitigation Tools
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
Data Integrity
Building a Corporate Data Integrity Program
Chinmoy Roy, Data Integrity and CSV SME, Industry Consultant, ValGenesis
Stability
Using Quality Risk Management (QRM) to Establish Critical Quality Attributes
Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP
12:30 - 1:15 PDT
Select Between Knowledge Exchange Sessions
Analytical
System Suitability Tests (SST) – Good Analytical Science
Stan Alekman, PhD., Independent Pharmaceutical Consultant, S.L. Alekman Associates, Inc.
Data Integrity
Compliance Strategies for the QC Analyst
John J. Long, Ph.D., Analytical Integrator, Biologics QC, Teva Branded Pharmaceuticals
Stability
Post Approval Change and Stability Testing
Junghae Scott, Principal, J Scott Consulting
1:30 – 2:00 PDT
Exhibitor Showroom and Think Tank Sessions
2:15 - 3:45 PDT
Select Between Knowledge Exchange Sessions
Analytical
Critical Elements for Analytical Method Transfer
Peju Odunusi, Ph.D., Owner, Pj Pharmaceutical Consulting
Data Integrity
Create Quality Cultures that Identify and Address Risks
Steve Thompson, Director Industry Solutions, ValGenesis
Stability
Application of Bracketing & Matrixing Designs in Stability Testing
Emily S. D. Trubee, MS, Stability Manager, Adare Pharmaceuticals
4:00 - 4:30 PDT
Exhibitor Showroom and Think Tank Sessions
4:45 - 6:15 PDT
Select Between Knowledge Exchange Sessions
Analytical / Stability
Validation of Stability-Indicating Analytical Methods
Commissioning Agents, Inc. (CAI)
Data Integrity
QC Audit Trails — Documents, Reports and Reviews
Sheba Zaman, Head of Product Specialists and Training Services, Novatek
Stability
Statistics in Stability Studies – Evaluating Data
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
6:15 PDT
Close of Day Two
7:00 PDT
Exhibitor Showroom Opens
Exhibitor Showroom Opens
Select Between Knowledge Exchange Sessions
Analytical
Determine Calibration Curves Using Regression Analysis
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
Data Integrity
Keeping Data Integrity in Mind While Qualifying Instruments
Heather Longden, Senior Marketing Manager, Waters Corporation
Stability
Building Effective and Efficient Stability Protocols
John O’Neill, Editor, StabilityHub
8:15 - 9:45 PDT
Select Between Knowledge Exchange Sessions
Analytical
OOS/OOT Investigations for Analytical Testing and Stability Studies
Junghae Scott, Principal, J Scott Consulting
Stability
Support and Elevate Your Stability Program with Computerized Tools
Sheba Zaman, Head of Product Specialists &Training Services, Novatek
Data Integrity
Understanding Data Pedigree to Assess Data Integrity and Quality Data Risk
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
10:00 - 10:30 PDT
Exhibitor Showroom and Think Tank Sessions
10:45 - 12:15 PDT
Select Between Knowledge Exchange Sessions
Analytical
Verification of Compendial Methods
John J. Long, Ph.D., Analytical Integrator, Biologics QC, Teva Branded Pharmaceuticals
Data Integrity
Data Integrity Process Mapping
Matthew LaPierre, Data Integrity Specialist
Stability
Implement Control Strategies to Monitoring Impurities through Pharmaceutical Development
Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP
1:30 - 2:00 PDT
Exhibitor Showroom and Think Tank Sessions
Analytical
System Suitability Establishment in and risk management Purity Methods for Protein Analysis
Liang Jia, Senior Manager, CMC Analytical, NGM Biopharmaceuticals
Data Integrity
How to Prepare for & Handle Laboratory Inspections
Robert J. Wherry, MSc, MS –Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals
Stability
Use of Accelerated Stability Modeling in Regulatory Filings
Kenneth C. Waterman, Ph.D., President, FreeThink Technologies, Inc.
2:15 - 3:45 PDT
Select Between Knowledge Exchange Sessions
Analytical
Root Cause Investigation to Overcome Analytical Method Transfer (AMT) and Validation (AMV) Challenges
Yasaman Bahreini, Validation and QA senior Consultant, Azzur Group
Data Integrity
Conduct a Data Integrity Audit and Gap Assessment
Steve Thompson, Director Industry Solutions, ValGenesis
Stability
Using Statistics for Process Capability, Stability and Control
Douglas B. Brown, Ph.D., Senior Scientist, Methods Development and Validations, Charles River Laboratories, Inc.
4:00 - 5:30 PDT
Select Between Knowledge Exchange Sessions
Analytical
Improper Use of Statistics – The Misuse, Misinterpretation and Bias of Analytical Assay Data
Douglas B. Brown, Ph.D., Senior Scientist, Methods Development and Validations, Charles River Laboratories, Inc
Data Integrity
Lab Data Integrity Case Studies – Program Implement and Overcoming Challenges
Alexander Margulis, Ph.D., Senior Director, Azzur Labs
Stability
Introduction to Medical Device Stability Testing
Chris Latoz, Stability Manager, Hollister Incorporated
5:30 PDT
Close of Conference
TEMPLE ON-DEMAND
Presented by:
Earn 1.5 credit unit hours by registering for this course!
By taking this on-demand course, you’ll be able to earn 1.5 credit unit hours. Once registered, KENX will send your log-in to our virtual conference which contains the designated Temple University sessions.
Take every designated Temple session on your time, the schedule is completely up to you!
You can also earn credits through our other courses such as Computer Systems Validation and Data Integrity Compliance Congress and Validation & GMP University.
Laboratory University
Laboratory University contains 3 amazing events all in one!
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!
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.
Faculty
Validation & GMP University
On-Demand
AGENDA
TEMPLE ON-DEMAND
Presented by:
Earn 1.5 credit unit hours by registering for this course!
By taking this on-demand course, you’ll be able to earn 1.5 credit unit hours. Once registered, KENX will send your log-in to our virtual conference which contains the designated Temple University sessions.
Take every designated Temple session on your time, the schedule is completely up to you!
You can also earn credits through our other courses such as Laboratory University and CSV & DI Compliance Congress.
VALIDATION UNIVERSITY
Missed Validation & GMP University?
No problem!
For a limited time, you can purchase the on-demand conference!
Access to all 55+ sessions
Watch any and every session you’ve checked off on your agenda. Access to the recorded sessions will be available until
September 25, 2020.
3,000 pages of content!
You will also receive the conference compendium with over 3,000 pages of fresh content, including all PowerPoint presentations, SOPs, checklists, master plans and more! Please note that the compendium can be viewed indefinitely after the event.
Once you purchase your ticket, you will receive a login to the on-demand conference site!
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 55 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.
55 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe
Facility Commissioning & Equipment Qualification
- Implement a Risk-based Verification Strategy
- Design a Risk-based IQ, OQ, and PQ Approach
- Manage Process Validation Tech Transfers
- Qualify Critical Utility Systems – HVAC, Water and Gas
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 Continued Process Verfications
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
- Stay up to speed with FDA’s Computer Software Assurance proposed draft
- Implement a Risk-Based CSV Program Enterprise-Wide
- Develop and Validate SAAS, IAAS, and Other Software Programs
- Qualify Network Infrastructure and Cloud Environments
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.
This Conference is Co-Located with DATA INTEGRITY INSPECTION READINESS SUMMIT with In-Depth Coverage On:
- Understand the Human Factor for Compliance
- Learn How to Build a Program from the Ground Up
- Identify the Root Cause of Inaccuracies
- Conduct an Audit/Gap Assessment and Implement Corrective Action
- Comply Across the GxP Environment
- Benchmark With Manufacturing, Laboratory and Clinical Top Companies
- Address Malicious Threats through Cybersecurity Best Practices
- Conduct Data Integrity Risk Assessments
- Know How to Handle Audit Trails
FACULTY
Computer Systems Validation &
Software Assurance University
AGENDA
TEMPLE ON-DEMAND
Presented by:
Earn 1.5 credit unit hours by registering for this course!
By taking this on-demand course, you’ll be able to earn 1.5 credit unit hours. Once registered, KENX will send your log-in to our virtual conference which contains the designated Temple University sessions.
Take every designated Temple session on your time, the schedule is completely up to you!
You can also earn credits through our other courses such as Laboratory University and Validation & GMP University
To this day, CSV and Data Integrity challenges remain high in our rapidly changing environment. In fact, FDA and other regulators continue to find serious findings including; 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. KENX is pleased to announce that our comprehensive CSV & DI Congress is headed to Philadelphia, PA, and showcases the protocols, methodology and actions necessary to avoid regulatory action.
Choose from Over 40+ Tutorials Addressing Today’s Top Challenges
COMPUTER SYSTEMS AND SOFTWARE VALIDATION
- Develop a Compliant-Winning Strategy to Migrate Electronic Records
- Understand FDA’s CSA Expectations and Proposed Draft
- Implement Process Mapping for IT Infrastructures
- Learn Machine Learning and AI Validation Techniques
- Conduct Risk-Based Impact Assessments and Continuous Monitoring
- Understand Pharma 4.0 and the Impact of Digitalization and IoT to CSV
- Implement Risk Management in Cloud-Based Exchange Systems
- Modernize the Periodic Review Process
- Overcome MS Excel Spreadsheet Validation
- Validate Cloud-hosted Systems and Network Infrastructures
DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS
- Conduct a Thorough and Accurate Gap Assessment
- Identify Gaps and Investigate Root Causes of Lapses
- Construct of a Program from the Ground Up
- Understand the Impact of Human Performance – Transform the Culture
- Implement an Effective Audit Trail Review Process
- Conduct a Risk-based Remediation
- Implement a CAPA Process – What to Do When Things Go Wrong
- Manage Corporate Challenges and Define Clear Roles and Responsibilities
- Learn How to Effectively Document Risks
Personnel in the Following Environments Should Attend:
- Validation
- Quality Assurance
- Engineering
- IT
- Data Integrity
- Quality Control
- Manufacturing Management
- Laboratory Management
- Regulatory Affairs
This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection and statistics.
