10:00 PT
Exhibitor Showroom and Virtual Platform Open House



10:45 PT
Chairman's Opening Remarks



11:00 - 11:45 PT
Compliance Trends, Metrics, and the Cost of Non-quality

Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Israel



11:45 - 12:30 PT
Quality Culture - Understand Human Impact in Your QMS

Kristin Shuler, Manager Site Quality Systems and Compliance, Curia



12:30 PT
Grab & Go Lunch and Exhibitor Showroom



1:30 - 2:30 PT
FDA Case for Quality (CfQ) initiatives and Flurry of Released Guidance(s) – VIP, CSA, GAMP 5 2nd EDITION, and Make CAPA Cool

"Moderator: Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group Panelists: Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA (Invited); Joseph Sapiente, Vice President, Clinical Science & Technology, Medical Device Innovation Consortium (MDIC); Garth Gonrad, Vice President, Quality - Flex Health Solutions; Robin Blankenbaker, Medical Device Quality Executive and IT Systems Program Management, Compliance Group"



2:30 - 3:15 PT
Mastering Remote Inspections Beyond Covid

Gaurav Walia, Senior Global Director of Business Development, PQE Group



3:15 - 3:45 PT
Exhibitor Showroom and Refreshment Break



3:45 - 4:15 PT
QRM- ICHQ9 Revision 1 Update – Review, Impact to the Industry and Implementation

Alice Redmond, Chief Strategy Officer, CAI



4:15 - 4:45 PT
Top Tips in Mastering Quality Systems Management

JR Humbert, Senior Director Quality, INCOG BioPharma



4:45 - 5:15 PT
Quality's Role in Speed to Patient

Lisa Sykes-Winstead, Site Quality Head, Senior Director, Resilience



5:00 PT
Networking Welcome Reception



7:15 PT
Exhibitor Showroom Opens and Lite Breakfast



7:55 - 8:35 PT
Select Between Knowledge Exchange Sessions



QUALITY SYSTEMS
Best Practice for Handling Testing and Production Batch Records

Joscelyn Bowersock, Therapeutics Implementation Lead and Solution Architect, L7 Informatics



CHANGE CONTROL
Conduct an Audit of Your Change Control Program

Erik Muegge, Site Quality Director, Abbott



QUALITY METRICS
FDA's Quality Metrics Movement - What You Need to Know to Get Started

Martina McDonagh, Associate Director Quality and Compliance, CAI



8:45 - 10:15 PT
Select Between Knowledge Exchange Sessions



QUALITY SYSTEMS
Risk-based Supplier Partnering and Auditing – During the Pandemic and Beyond

Cinta Burgos, Vice President Consulting Services, Azzur Group



CHANGE CONTROL
Building a Change Control Program From the Ground Up

Roque Redondo, Senior Technical Consultant, PharmEng Technology



QUALITY METRICS
Measure Manufacturing Process Performance – Process Capability/Performance, Lot Acceptance Rate (LAR), Right-First-Time Rate, Lot Release Cycle Time

Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Israel



10:15 - 10:45 PT
Exhibitor Showroom and Refreshment Break



10:45 - 11:25 PT
Select Between Knowledge Exchange Sessions



QUALITY SYSTEMS
SOPs - Writing Quality Procedures that Survive the Lifecycle

Kim Huynh-Ba, Managing Director, Pharmalytik Consulting; Adjunct Faculty, Regulatory Compliance, Illinois Institute of Technology (IIT)



CHANGE CONTROL
Conducting Impact Assessments as Part of Change Control

Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, CAI



QUALITY METRICS
Equipment Effectiveness and Maintenance – The Good, The Bad and The Unexpected

Erika Roberts, Senior Scientist Quality Assurance, Pace Analytical Life Sciences



11:35 - 12:15 PT
Select Between Knowledge Exchange Sessions



QUALITY SYSTEMS
How Do You Know? Evaluating Effectiveness of a GxP Training Program

Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics



CHANGE CONTROL
Integrate Risk Management into Change Control Procedures

Connie Hetzler, Global Head – Validation, Alcon Laboratories



QUALITY METRICS
How to Increase and Achieve Right First Time Rates

Kathy Simon Ph.D., Vice President of Quality Control, Medicago



12:15 PT
Exhibitor Showroom and Grab & Go Lunch



12:45 - 1:25 PT
Select Between Knowledge Exchange Sessions



QUALITY SYSTEMS
“Don’t Deviate from the Plan!” – How to Minimize Deviations and Implement Effective Corrective Actions

Erika Roberts, Senior Scientist Quality Assurance, Pace Analytical Life Sciences



CHANGE CONTROL
Good Documentation Practice - Well Written Procedures, SOP's, Forms, and Checklists

Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc.



QUALITY METRICS
Learn Effective Strategies to Ensure Supply Chain Robustness

Bryan Ennis, CEO, and Kosal Keo, CTO, BTR



1:35 -3:05 PT
Select Between Knowledge Exchange Sessions



QUALITY SYSTEMS
Laboratory Controls - Ensure Cleanliness, Control, Accuracy, Quality, and Safety

Kathy Simon, Ph.D., Vice President of Quality Control, Medicago



CHANGE CONTROL
Change Control for Computer Systems and Software Upgrades

Micheal Brunner, Senior Validation Engineer, Takeda



QUALITY METRICS
Learn How to Evaluate Your Quality System Effectiveness

Lisa Sykes-Winstead, Site Quality Head, Senior Director, Resilience



3:05 PT
Exhibitor Showroom and Afternoon Stretch



3:30 - 5:00 PT
Select Between Knowledge Exchange Sessions



QUALITY SYSTEMS
Master Process Validation as Part of Your Quality System

David DeLuca, Manager - Validation and Data Integrity, Compliance Group



CHANGE CONTROL
Impact Assessments for Supplier Changes

Alan Golden, Principal, Design Quality Consultants



QUALITY METRICS
Quality Metrics Think Tank - Insight from the Front Line

Dori Gonzalez-Acevedo, CEO, ProcellaRX



5:00 PT
Close of Day Two



7:15 PT
Exhibitor Showroom Opens and Lite Breakfast



7:55 - 8:35 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Building and Managing Your Audit Team

Kim Huynh-Ba, Managing Director, Pharmalytik Consulting; Adjunct Faculty, Regulatory Compliance, Illinois Institute of Technology (IIT)



RISK MANAGEMENT
Mastering the Most Common Risk Tools in Your QMS

Kristin Shuler, Manager Site Quality Systems and Compliance, Curia



STATS & TRENDING
Moving to Objective, Data-Driven Decisions – The Who, What, When, Where, Why, and How of Statistics

Tara Scherder, Principal, SynoloStats LLC



8:45 - 10:15 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Design Your Custom Audit Checklist

David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences



RISK MANAGEMENT
Risk-Based Thinking – Maximize your ROI on Risk Assessments – A Practical, Resource Effective Approach to Risk Management

Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Israel



STATS & TRENDING
Using Statistics as a Risk Tool throughout the Process Validation Lifecycle

Tara Scherder, Principal, SynoloStats LLC



10:15 - 10:45 PT
Exhibitor Showroom and Refreshment Break



10:45 - 11:25 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Learn Best Practices for Conducting Mock Audits

Erik Muegge, Site Quality Director, Abbott



RISK MANAGEMENT
How to Use Risk Throughout the Process Validation Lifecycle

Connie Hetzler, Global Head – Validation, Alcon Laboratories



STATS & TRENDING
Optimize Sampling Plans to Demonstrate Process Performance

Alan Golden, Principal, Design Quality Consultants



11:35 - 12:15 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Bridging the Communication Gap Between Quality and Operations

Shannon Chesterfield, Senior Director, Consulting, Azzur Group



RISK MANAGEMENT
Using Risk Assessments to Minimize Cross Contamination

Wendy Haines, Ph.D., Director of Toxicology and Laboratory Services, PharmEng Technology



STATS & TRENDING
Use Statistical Analysis for Setting Acceptance Criteria

Alan Golden, Principal, Design Quality Consultants



12:15 PT
Exhibitor Showroom and Grab & Go Lunch



12:45 - 1:25 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Preparing Your Firm for an FDA Inspection

Erik Muegge, Site Quality Director, Abbott



RISK MANAGEMENT
Learn How to Create and Use a Customized Risk Tool

Steven Thompson, Director Industry Solutions, ValGenesis



STATS & TRENDING
Develop a Control Strategy Using Design of Experiments (DOE)

Katherine Giacoletti, Principal Scientist, Center for Mathematical Scientists, Merck & Co., Inc.



1:35 - 2:15 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Essential Tips for Handling Investigators During the Inspection

Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc.



RISK MANAGEMENT
Successful FMEA Training and Continual Improvement

Connie Hetzler, Global Head – Validation, Alcon Laboratories



STATS & TRENDING
Use of Modern Statistical Tools for Accelerated Development & Novel Therapies

Katherine Giacoletti, Principal Scientist, Center for Mathematical Scientists, Merck & Co., Inc.



2:25 - 3:05 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Learn How to Respond to FDA Warning Letters

JR Humbert, Senior Director Quality, INCOG BioPharma



RISK MANAGEMENT
Rank Risk and Filter for Identification

Roger Ouimet, Principal Consultant, CAI



STATS & TRENDING
Leverage Data Visualization to Speed Root Cause Analysis

Tara Scherder, Principal, SynoloStats LLC



3:05 PT
Exhibitor Showroom and Afternoon Stretch



3:30 - 4:15 PT
Select Between Knowledge Exchange Sessions



AUDITS & INSPECTIONS
Integrate Risk Management into Your Audit Program

David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences



RISK MANAGEMENT
Data Tracking and Monitoring the Outputs of Risk Assessments

Joscelyn Bowersock, Therapeutics Implementation Lead and Solution Architect, L7 Informatics



STATS & TRENDING
Stability Testing Statistics in Practice - An Implementation Example

Emily Dickinson, MS, ASQ, CQA, Quality Assurance Manager, Criterium, Inc.



4:15 PT
Close of Day Three





CAI





BTR







The Hilton Gaslamp
San Diego, CA

Are you a life science professional in charge of ensuring your firm is compliant with GMPs throughout the Pharmaceutical Quality System? Are you up-to-speed in 21 CFR Part 211 regulatory expectations and compliance trends? Did you know FDA renewed their interest in Quality Metrics by asking for public comments suggesting an FDA guideline is moving forward? Would you like to understand GMP statistics and data trending to use risk and deviation tool? Are you still having issues with Data Integrity? If your answer is yes, don’t walk – run to this event to keep you up-to-the-minute with GMP regulations and compliance trends, best in class procedures/documentation and the innovative technology platforms to get you there.

Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Single Admission - GMP University
Main conference & inclusive workshops
$ 2,595.00 $2,595.00
Unlimited
Team Discount - Register 3 with 4th Free - GMP University
Team Discount - Register 3, 4th Free. (3x$2295)=$6885 with 4th Free.
$ 1,946.25 $1,946.25
Unlimited
Temple Track - GMP University
Temple Track - Main Conference Ticket with Additional $995 paid directly to Temple University
$ 2,595.00 $2,595.00
Unlimited

CREATE YOUR OWN EVENT – 6 TRACKS with 45+ SESSIONS! HIGHLIGHTS INCLUDE:

QUALITY RISK MANAGEMENT

  • Maximize your ROI on Risk Assessments – A Practical, Resource Effective Approach
  • How to Use Risk Throughout the Process Validation Lifecycle
  • Successful FMEA Training and Continual Improvement
  • Learn How to Create and Use a Customized Risk Tool

CHANGE CONTROL PROGRAM MANAGEMENT

  • Conducting Impact Assessments as Part of Change Control
  • Integrate Risk Management into Change Control Procedures
  • Good Documentation Practice – Well Written Procedures, SOP’s, Forms, and Checklists
  • Change Control for Computer Systems and Software Upgrades

AUDITS & INSPECTIONS 

  • Building and Managing Your Audit Team and Design a Custom Checklist
  • Learn Best Practices for Conducting Mock Audits
  • Bridging the Communication Gap Between Quality and Operations
  • Preparing Your Firm for an FDA Inspection

QUALITY METRICS 

  • Learn Effective Strategies to Ensure Supply Chain Robustness
  • Measure Manufacturing Process Performance – Process Capability/Performance, Lot Acceptance Rate (LAR), Right-First-Time Rate, Lot Release Cycle Time
  • Equipment Effectiveness and Maintenance – The Good, The Bad and The Unexpected

QUALITY SYSTEMS MANAGEMENT

  • Best Practice for Handling Testing and Production Batch Records
  • Risk-based Supplier Partnering and Auditing – During the Pandemic and Beyond
  • SOPs – Writing Quality Procedures that Survive the Lifecycle
  • Minimize Deviations and Implement Effective Corrective Actions

STATISTICS IN VALIDATION

  • Moving to Objective, Data-Driven Decisions
  • Using Statistics as a Risk Tool throughout the Process Validation Lifecycle
  • Optimize Sampling Plans to Demonstrate Process Performance
  • Use Statistical Analysis for Setting Acceptance Criteria

Who 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.



Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Single Admission - GMP University
Main conference & inclusive workshops
$ 2,595.00 $2,595.00
Unlimited
Team Discount - Register 3 with 4th Free - GMP University
Team Discount - Register 3, 4th Free. (3x$2295)=$6885 with 4th Free.
$ 1,946.25 $1,946.25
Unlimited
Temple Track - GMP University
Temple Track - Main Conference Ticket with Additional $995 paid directly to Temple University
$ 2,595.00 $2,595.00
Unlimited