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Archive for category: Temple On-Demand

You are here: Home1 / Temple On-Demand
Temple On-Demand

TEMPLE ON-DEMAND: LABORATORY UNIVERSITY

LABORATORY UNIVERSITY

AGENDA

  • DAY ONE - October 5, 2020
  • DAY TWO - October 6, 2020
  • DAY THREE - October 7, 2020
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



SPONSORS




July 23, 2020

Azzur Group

July 23, 2020

CAI

July 23, 2020

Ellab





July 23, 2020

CIMCON Software

July 23, 2020

H&A Scientific

July 23, 2020

Kaye

July 23, 2020

Neva Analytics

July 23, 2020

Novatek International

July 23, 2020

QACV

July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

July 23, 2020

Waters Corporation

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite

Faculty


Alexander Margulis

Stanley Alekman

Douglas Brown

Emily S. D. Trubee

Maria E. Orpilla

Kenneth Waterman

Patrick Kelleher

Junghae Scott

John Long

Liang Jia

Yasaman Bahreini

Isabelle Vu Trieu

Heather Longden

Robert J. Wherry

Geoff Carr

John O’Neill

Christopher Latoz

Leonel Santos

Sanjay Agrawal

Sheba Zaman

Chinmoy Roy

Steven Thompson

Raul Soto

Ronald D. Snee

Peju Odunusi

Matthew LaPierre

Steven Kuwahara

Kim Huynh-Ba

December 21, 2020/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2020/07/KENX-04.jpg 1035 1693 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2020-12-21 15:35:072020-12-21 15:36:12TEMPLE ON-DEMAND: LABORATORY UNIVERSITY
Temple On-Demand

TEMPLE ON-DEMAND: VALIDATION AND GMP UNIVERSITY

Validation & GMP University
On-Demand

AGENDA

SPONSORS



July 23, 2020

Azzur Group

July 23, 2020

Ellab





July 23, 2020

CAI

July 23, 2020

Kaye





July 23, 2020

Aventior

July 23, 2020

CIMCON Software

July 23, 2020

H&A Scientific

July 23, 2020

Lighthouse Worldwide Solutions

July 23, 2020

Novatek International

July 23, 2020

PharmaLex

July 23, 2020

QACV

July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

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

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite

FACULTY


Susan Cleary

Sanjay Agrawal

Gerardo Gomez

William T. Drummond Jr.

Tara Scherder

Steven Thompson

David W. Vincent

Jason Kelly

Fred Ohsiek

Raul Soto

Ronald D. Snee

Ken Shitamoto

Roque Redondo

Peju Odunusi

Dennis Plante

James Mason

Matthew LaPierre

Steven Kuwahara

Philip Jarvis

Kim Huynh-Ba

Connie Hetzler

Senthil Gurumoorthi

Alan M Golden

Katherine Giacoletti

Danielle Duran

Anthony Chikere

Chip Bennett

Brent Gendelman

Shelley Preslar

Christopher Robitaille

Thomas Miller

Abhijit Ray

J. Loren Smith

Kim Munsell

Patrick Mullin

Chris Maughan

Eric Collier

Gamal Amer

Adil Seddiq

December 18, 2020/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2020/07/KENX-01-e1595580558224.jpg 248 406 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2020-12-18 22:12:122020-12-18 22:15:23TEMPLE ON-DEMAND: VALIDATION AND GMP UNIVERSITY
Temple On-Demand

TEMPLE ON-DEMAND: COMPUTER & SOFTWARE VALIDATION & DATA INTEGRITY COMPLIANCE CONGRESS

COMPUTER & SOFTWARE VALIDATION
& DATA INTEGRITY COMPLIANCE CONGRESS

AGENDA

SPONSORS



July 23, 2020

CAI





July 23, 2020

Aventior

July 23, 2020

Azzur Group

July 23, 2020

CIMCON Software

October 15, 2020

CompliancePath

July 23, 2020

H&A Scientific

November 9, 2020

Validify





September 28, 2020

Compliance Group

July 23, 2020

Novatek International

July 23, 2020

VALGENESIS

July 23, 2020

VTI Life Sciences

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.

Download Brochure

Sponsorship Inquiry


Pricing & Registration

Powered by Eventbrite

Faculty


Irving Bruckstein

Ido Raz

Zahid Muhammad

Stephen Ferrell

Jon Thompson

Erik Muegge

Shana Kinney

Holly Baldwin

Leslie Lighton-Humphreys

Carlos Pereira

Cynthia Duhigg

Khaled Moussally

Harsha Chulki

Stephen J Cook

John Hannon

Calvin Kim

Joseph Zec

William Honeck

Dan Grill

April Bunje

Teri Stokes

Pritam Khade

Vishal Kadakia

Eric Henry

Loganathan Kumarasamy

Raechelle Raimondo

Pritam Khade

Kevin Martin

Robert J. Wherry

Sanjay Agrawal

Chinmoy Roy

Steven Thompson

David W. Vincent

Raul Soto

Ken Shitamoto

Matthew LaPierre

Senthil Gurumoorthi

Donnacha J. Nagle

Christopher Robitaille

December 18, 2020/by Jonathan Driscoll
https://kenx.org/wp-content/uploads/2020/07/KENX-12.jpg 1035 1693 Jonathan Driscoll https://kenx.org/wp-content/uploads/2020/01/KENx-logo-300x104.png Jonathan Driscoll2020-12-18 14:46:092020-12-18 22:03:50TEMPLE ON-DEMAND: COMPUTER & SOFTWARE VALIDATION & DATA INTEGRITY COMPLIANCE CONGRESS

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