BIOPHARMACEUTICAL MANUFACTURING
UNIVERSITY
AGENDA
11:00 AM
Registration & Exhibitor Showroom and Virtual Platform Open House
1:00 PM
Chairman’s Opening Remarks
1:15 PM
Examining Next Generation Biopharmaceutical Manufacturing
2:00 PM
Panel Discussion: Discovering how Covid-19 has Changed Biopharmaceutical Manufacturing Forever Delivery
3:00 - 3:30 PM
Exhibitor Showroom and Think Tank Sessions
3:45 PM
Using Process Analytical Technology (PAT) Tools in Biopharmaceutical & Pharmaceutical Manufacturing
Venkatesh Srinivasan | Vice President, Global MSAT-BT | Bayer
3:45 PM
Creating the Biopharma Workforce of the Future
Ashley Boucher | Owner/Founder | Quality Control Analytics
4:30 PM
Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
4:30 PM
Advantages and Challenges of Implementing N-1 Perfusion Technology
4:45 PM
Data Integrity and Biopharmaceutical Manufacturing
5:30
Game Night - Trivia Welcome Reception
8:00 AM
Registration & Breakfast
8:45 AM
Opening Remarks
9:00 AM
Creating an Agile Culture to Be Ready to Adapt to New Innovative Ways of Working
Jordyne Blaise | Director of Diversity, Equity & Inclusion | Bluebirdbio
9:50 AM
The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 During Covid-19
10:35 AM
Networking Break
11:00 AM
Optimizing Gene Therapy Supply Chains to Accelerate Drug Development
11:00 AM
Remote Monitoring and Big Data Advance Upstream Automation and on-line monitoring in BioPharma Manufacturing
Cierra Britt | Biopharm Manufacturer Associate I | GlaxoSmithKline (GSK)
11:45 AM
Remote Observation Technologies – Revolutionizing the Pharma Manufacturing Space
11:45 AM
Building a Modern Manufacturing Enterprise on the Foundation of IoT, Data-Driven Decision-Making and Digital Technologies
12:30 PM
Lunch
1:40 PM
Removing Bottlenecks: Improving the Supply Chain for the Biopharma Industry – What Covid-19 Vaccine Production Taught Us
Chor Sing Tan | Strategy Manager Growth Initiatives | Cytiva
2:15 PM
The Changing Regulatory Processes After the Global Pandemic
2:15 PM
Data Analytics in Biopharma Manufacturing
2:15 PM
Rapid and Cost-Effective Deployment of Modular Biopharma Manufacturing Facilities
Chor Sing Tan | Strategy Manager Growth Initiatives | Cytiva
2:55 PM
Exhibitor Showroom and Think Tank Sessions
3:25 PM
Networking Break
3:40 PM
Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
Priya Baraniak | Vice President, Corporate Development | OrganaBio
4:15 PM
Elevating Biopharma Manufacturing Through Artificial Intelligence (AI) & Machine Learning
Maria Papathanasiou | Lecturer | Imperial College London
5:00 PM
Cocktail Reception
8:15 AM
Registration & Breakfast
8:55 AM
Opening Remarks
9:00 AM
Reflecting on the Growing Momentum for Biosimilars in the US
9:45 AM
Continuous Manufacturing Technology: Improving Drug Manufacturing Efficiency
10:25 AM
Networking Break
10:45 AM
Leveraging Flexible Networks, Cutting-Edge Innovation in a Quality Culture
10:45 AM
Realizing the Paradigm Shift to a Smarter Manufacturing Process
Chor Sing Tan | Strategy Manager Growth Initiatives | Cytiva
11:45 AM
Exhibitor Showroom & Think Tanks
12:30 PM
Networking Luncheon
1:45 PM
Supply Chain Resiliency – Manage Through Disruption
2:45 PM
The New Operating Model for Smart Manufacturing: Agility, Resiliency, Flexibility
3:30 PM
Closing Remarks
3:45 PM
End of Biopharmaceutical Manufacturing University
BIOPHARMACEUTICAL MANUFACTURING UNIVERSITY
November 9th – 11th
Take Advantage of Early Bird pricing through October 1st!
More than ever before, the past 18 months has outlined the need for rapid, scalable and cost-effective vaccine, diagnostic, and therapeutic development. It also showcased the importance of flexibility and the need for the biopharmaceutical manufacturing industry to adapt to changing market demands. KENX is excited to announce the Biopharmaceutical Manufacturing University event taking place November 9 – 11 in San Diego. This hybrid-format program will provide you with real world case studies and industry insights as to how the biopharma manufacturing industry can transform for a better future.
Topics Being Covered at the Biopharmaceutical Manufacturing University Hybrid Event Include:
- Understanding Process Validation in Biotechnology Manufacturing
- Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
- Examining How New Technologies are Affecting Biopharmaceutical Manufacturing
- Reflecting on the Growing Momentum for Biosimilars in the US
- Creating an Agile Culture to Be Ready to Adapt to New Innovative Ways of Working
- Discovering how Covid-19 has Changed Biopharmaceutical Manufacturing Forever Delivery
- Removing Bottlenecks: Improving the Supply Chain for the Biopharma Industry
- Data Integrity and Biopharmaceutical Manufacturing
- Remote Observation Technologies – Revolutionizing the Pharma Manufacturing Space
- Technology Advancements for Drug Product Manufacturing
- Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
- The Changing Regulatory Processes after The Global Pandemic
- Cautionary Tales of Centralized Pharmaceutical Manufacturing
- Advances in Next-Generation Drug Substance Manufacturing of Biologics
- The Digitization of CMC – The Future for Regulatory Submissions
- Moving from Change Management to Enterprise Transformation
- What is the Vision for AI in Biopharma Manufacturing?
- Data Analytics in Biopharma Manufacturing
- Barriers to User-Adoption of Innovative Technology in Biopharmaceutical Manufacturing
- The Potential of Hybrid Process Modeling and Digital Twins to Master the Goals of Bioprocessing 4.0
- What Does a Modern BioPharmaceutical Manufacturing Facility Look Like?
- The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 During Covid
- Rapid and Cost-Effective Deployment of Modular Biopharma Manufacturing Facilities
Who Should Attend:
Attendees will come from biopharmaceutical companies, pharma, biotech companies, medtech companies and their peripherals across the globe and will bring together all those individuals involved with the manufacturing process.
Titles will include:
- Chief Engineering Officer
- Chief Manufacturing Officer
- Chief Scientific Officer
- Chief Innovation Officer
- Chief Technology Officer
- Chief Operations Officer
- Chief Quality Officer
- Chief Data Analytics Officer
VPs/Directors/Managers & Heads of:
- Manufacturing
- Engineering
- R&D / Research & Development
- Process Improvement
- Quality
- Supply Chain
- Operations
- Innovation
- Plant/Site/Facilities
- Quality
- Strategy
- Business Development
- Technology
- IT/Information Technology
- AI
- Data & Analytics
PROCESS VALIDATION &
CONTINUED VERIFICATION
AGENDA
12:00 ET
Registration and Exhibitor Showroom Openhouse
1:15 ET
Chairman's Opening Remarks
1:15 - 2:15
FDA Compliance Roundtable – Agency Insight, Updates, and Trends
James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)
2:15 - 2:45 ET
Understanding Human Behavior and Quality Culture in Validation and GMP Operations
Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics, a Nestle Health Sciences Company
2:45 ET
Exhibitor Showroom and Refreshment Break
3:15 - 4:00 ET
Process Validation and Continued Verification — A Risk-based Implementation Case Study
Javier Cardenas, Ph.D., Senior Consultant, Technical Lead, Azzur Group
4:00 - 4:30 ET
Validation Master Plans (VMP), Protocols and Reports - Discover Best in Procedural Templates
JR Humbert, Senior Director Quality, INCOG Biopharma
4:30 - 5:00 ET
Annex 1 Contamination Control — What the Recent Revision Means for Validation
Parsa Famili, President & CEO, NOVATEK INTERNATIONAL
5:00 ET
Game Night - Trivia Welcome Reception
7:30 ET
Exhibitor Showroom and Light Breakfast
8:20 - 9:05
Select Between Knowledge Exchange Sessions (1-4)
1
Conduct a Gap Analysis of Your Validation Program
Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, CAI
2
Supplier Qualification - Create and Maintain Quality Agreements
JR Humbert, Senior Director Quality, INCOG Biopharma
3
Single Use Systems (SUSs) - Implementation and Validation
David W Vincent, MPH, Ph.D., CEO, VTI Life Sciences
4
Data Integrity Risk Assesements and Process Mapping
Chinmoy Roy, Senior Industry Consultant, ValGenesis
9:15 -10:00 ET
Select Between Knowledge Exchange Sessions (5-8)
5
Supply Chain Validation - Lessons Learned During Covid-19
To Be Announced
6
FDA Inspection Management — Tips that Impress Investigators
Mony Clark, Senior Manager, QA Compliance, Genmark Dx - Roche Diagnostics
7
Align Your CSV Program with FDA’s Proposed CSA Guidance
Joseph Zec, R&D CSV/Process QA and Compliance Leader, Takeda
8
Data Integrity Programs — Case Study Examples
Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting
10:00 ET
Exhibitor Showroom and Refreshment Break
10:00 - 12:00 ET
Select Between Knowledge Exchange Sessions (9-12)
9
Lean Validation — Ensure Quality While Reducing Costs
Phil Jarvis, Global C&Q lead for EU, AbbVie Jerry Quirke, Lead Process Engineer, Kneat Solutions
10
Risk-based Cleaning Validation - Key Elements for Success
Susan B. Cleary, B.Cs, M.B.A., Director of Product Development, NOVATEK INTERNATIONAL
11
Critical Thinking and Change Management — Lessons Learned from the CSA Movement
Ken Shitamoto Senior Director, IT Gilead Sciences
12
Data Integrity — Assessment, Implementation, and Maintenance
Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)
12:00 ET
Grab & Go Lunch and Think Tank Sessions
12:30 - 1:00 ET
Select Between Knowledge Exchange Sessions (13-16)
13
Overcome the Top 5 Validation Challenges
Gerardo Gomez, Ph.D., Director QMC-US, Pharmalex
14
Common Gaps in Cleaning Validation and Their Solutions — From Pain to Optimization
TJ Woody, Director of Cleaning Validation, Azzur Group
15
Learn How to Use Effective Risk-based Decision Making in Validation
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
16
Ensure Data Integrity by Design (DIbD) — The Right Data, Right from the Start
Steve Thompson, Director Industry Solutions, ValGenesis
1:30 - 3:00 ET
Select Between Knowledge Exchange Sessions (17-20)
17
Case Study — Implementing a Risk-based Process Validation Life Cycle Approach
Connie Hetzler, Global Head – Validation, Alcon Laboratories (Invited)
18
Process Validation Statistics for Non-statisticians
Alan Golden, MS, Principal, Design Quality Consultants, LLC
19
CSV Hot Topics — SaaS, Spreadsheets, Network Qualification, Clouds, Mobile Technology and Digitalization
Carlos Pereira, Regional Manager of U.S. Midwest and Canada, VTI Life Sciences
20
Cultivate the Culture of Integrity in Data Management
Roque Redondo, VP Automation and Business Development USA Operations, mirus
3:00 ET
Exhibitor Showroom and Refreshment Break
3:30 - 5:00 ET
Select Between Knowledge Exchange Sessions (21 -24)
21
Validation & Verification — A Medical Device Master Class
Melissa Brookshier, Director, Azzur Group
22
Statistical Process Control and The Use Of Control Charts
Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River
23
Take a Risk-based Approach to Audit Trail Reviews
Joseph Zec, R&D CSV/Process QA and Compliance Leader, Takeda
24
Build Your Custom Audit Checklist – Master Class
Mony Clark, Senior Manager, QA Compliance, Genmark Dx - Roche Diagnostics
5:00 ET
Close of Day Two
7:30 ET
Exhibitor Showroom Opens
8:20 - 9:05 ET
Select Between Knowledge Exchange Sessions (25-28)
25
Risk-based Commissioning & Qualification — Successful Development and Execution
Donncha Nagle, Commissioning, Qualification & Validation Lead, Jacobs Engineering Group; and Researcher, TU Dublin
26
Validation Statistics — Strategies to Graph, Analyze, and Present Data Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Car
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care
27
Cleaning Validation Hot Topics — Documentation, Acceptance Criteria and Health Limits
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
28
Learn How to Conduct a Mock Inspection in Preparation for an Audit
Eric Henry, Senior Quality Systems and Compliance Advisor, FDA and Life Science Practice, King & Spalding
9:15 - 10:00 ET
Select Between Knowledge Exchange Sessions (29-32)
29
Optimize Process Performance – Implement an Effective Quality Monitoring System
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
30
Conduct Remote Virtual Factory Acceptance Testing (FAT)
Donncha Nagle, Commissioning, Qualification & Validation Lead, Jacobs Engineering Group; and Researcher, TU Dublin
31
Leverage Digital Validation for Streamlined Risk-Based Testing
Dori Gonzalez-Acevedo, VP of Strategic Solutions, Tx3 Services
32
Learn How to Use Risk in Change Control Processes
Roque Redondo, VP Automation and Business Development USA Operations, mirus
10:00 ET
Exhibitor Showroom and Refreshment Break
10:30 - 12:00 ET
Select Between Knowledge Exchange Sessions (33-36)
33
Critical Utility Qualification and Environmental Monitoring Performance Qualification
Elizabeth Brockson, Associate Director, Global Quality Control, CAI
34
Apply Quality by Design (QbD) for all Validation Types — QbD for All
Steve Thompson, Director Industry Solutions, ValGenesis
35
What to Do When Things Go Wrong — Implement an Effective CAPA Program
Shannon Chesterfield, Senior Director of Consulting, Azzur Group
36
Mastering the Critical Elements of a Quality Risk Management (QRM) Program
Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, CAI
12:00 ET
Grab & Go Lunch and Think Tank Sessions
1:30 - 3:00 ET
Select Between Knowledge Exchange Sessions (37-40)
37
Personnel Training — Hiring People that Make Validation Great
Mark Cheshire, Business Development Manager, H&A Scientific
38
Use Validation Sampling Plans for Critical Decisions
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
39
Analytical Method Validation — What Quality and Process Professionals Need to Know
Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)
40
Change Control - Conduct System Criticality and Impact Assessments
Alan Golden, MS, Principal, Design Quality Consultants, LLC
3:00 ET
Exhibitor Showroom and Refreshment Break
3:15 - 4:45 ET
Select Between Knowledge Exchange Sessions (41-44)
41
Assay Transfer, Qualification, Validation — Are We Living in a ‘Land of Confusion’?
Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River
42
Qualification of Temperature Mapping and Storage Chambers
Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
43
Statistical Process Control Charts — Analyzing Process Performance
Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River
44
Validation and Change Control — Null Hypothesis Significant Testing
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care
4:45 ET
Close of Conference
Process Validation & Continued Process Verification (CPV)
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. Come to this virtual event this spring and 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.
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
Validation & GMP University
AGENDA
12:00 ET
Registration and Exhibitor Showroom Openhouse
1:15 ET
Chairman's Opening Remarks
1:15 - 2:15 ET
FDA Compliance Roundtable – Agency Insight, Updates, and Trends
James Mason, PharmD, Compliance Officer, OPQO, U.S. FDA (Invited)
2:15 - 2:45 ET
Understanding Human Behavior and Quality Culture in Validation and GMP Operations
Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics, a Nestle Health Sciences Company
2:45 ET
Exhibitor Showroom and Refreshment Break
3:15 - 4:00 ET
Process Validation and Continued Verification — A Risk-based Implementation Case Study
Javier Cardenas, Ph.D., Senior Consultant, Technical Lead, Azzur Group
4:00 - 4:30 ET
Validation Master Plans (VMP), Protocols and Reports - Discover Best in Procedural Templates
JR Humbert, Senior Director Quality, INCOG Biopharma
4:30 - 5:00 ET
Annex 1 Contamination Control — What the Recent Revision Means for Validation
Parsa Famili, President & CEO, NOVATEK INTERNATIONAL
5:00 ET
Game Night - Trivia Welcome Reception
7:30 ET
Exhibitor Showroom and Light Breakfast
8:20 - 9:05 ET
Select Between Knowledge Exchange Sessions (1-4)
1
Conduct a Gap Analysis of Your Validation Program
Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, CAI
2
Supplier Qualification - Create and Maintain Quality Agreements
JR Humbert, Senior Director Quality, INCOG Biopharma
3
Single Use Systems (SUSs) - Implementation and Validation
David W Vincent, MPH, Ph.D., CEO, VTI Life Sciences
4
Data Integrity Risk Assesements and Process Mapping
Chinmoy Roy, Senior Industry Consultant, ValGenesis
9:15 - 10:00 ET
Select Between Knowledge Exchange Sessions (5-8)
5
Supply Chain Validation - Lessons Learned During Covid-19
To Be Announced
6
FDA Inspection Management — Tips that Impress Investigators
Mony Clark, Senior Manager, QA Compliance, Genmark Dx - Roche Diagnostics
7
Align Your CSV Program with FDA’s Proposed CSA Guidance
Joseph Zec, R&D CSV/Process QA and Compliance Leader, Takeda
8
Data Integrity Programs — Case Study Examples
Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting
10:00 ET
Exhibitor Showroom and Refreshment Break
10:00 - 12:00 ET
Select Between Knowledge Exchange Sessions (9-12)
9
Lean Validation — Ensure Quality While Reducing Costs
Phil Jarvis, Global C&Q lead for EU, AbbVie Jerry Quirke, Lead Process Engineer, Kneat Solutions
10
Risk-based Cleaning Validation - Key Elements for Success
Susan B. Cleary, B.Cs, M.B.A., Director of Product Development, NOVATEK INTERNATIONAL
11
Critical Thinking and Change Management — Lessons Learned from the CSA Movement
Ken Shitamoto Senior Director, IT Gilead Sciences
12
Data Integrity — Assessment, Implementation, and Maintenance
Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)
12:00 ET
Grab & Go Lunch and Think Tank Sessions
12:30 - 1:00 ET
Select Between Knowledge Exchange Sessions (13-16)
13
Overcome the Top 5 Validation Challenges
Gerardo Gomez, Ph.D., Director QMC-US, Pharmalex
14
Common Gaps in Cleaning Validation and Their Solutions — From Pain to Optimization
TJ Woody, Director of Cleaning Validation, Azzur Group
15
Learn How to Use Effective Risk-based Decision Making in Validation
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
16
Ensure Data Integrity by Design (DIbD) — The Right Data, Right from the Start
Steve Thompson, Director Industry Solutions, ValGenesis
1:30 - 3:00 ET
Select Between Knowledge Exchange Sessions (17-20)
17
Case Study — Implementing a Risk-based Process Validation Life Cycle Approach
Connie Hetzler, Global Head – Validation, Alcon Laboratories (Invited)
18
Process Validation Statistics for Non-statisticians
Alan Golden, MS, Principal, Design Quality Consultants, LLC
19
CSV Hot Topics — SaaS, Spreadsheets, Network Qualification, Clouds, Mobile Technology and Digitalization
Carlos Pereira, Regional Manager of U.S. Midwest and Canada, VTI Life Sciences
20
Cultivate the Culture of Integrity in Data Management
Roque Redondo, VP Automation and Business Development USA Operations, mirus
3:00 ET
Exhibitor Showroom and Refreshment Break
3:30 - 5:00 ET
Select Between Knowledge Exchange Sessions (21 -24)
21
Validation & Verification — A Medical Device Master Class
Melissa Brookshier, Director, Azzur Group
22
Statistical Process Control and The Use Of Control Charts
Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River
23
Take a Risk-based Approach to Audit Trail Reviews
Joseph Zec, R&D CSV/Process QA and Compliance Leader, Takeda
24
Build Your Custom Audit Checklist – Master Class
Mony Clark, Senior Manager, QA Compliance, Genmark Dx - Roche Diagnostics
5:00 ET
Close of Day Two
7:30 ET
Exhibitor Showroom Opens
8:20 - 9:05 ET
Select Between Knowledge Exchange Sessions (25-28)
25
Risk-based Commissioning & Qualification — Successful Development and Execution
Donncha Nagle, Commissioning, Qualification & Validation Lead, Jacobs Engineering Group; and Researcher, TU Dublin
26
Validation Statistics — Strategies to Graph, Analyze, and Present Data Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Car
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care
27
Cleaning Validation Hot Topics — Documentation, Acceptance Criteria and Health Limits
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
28
Learn How to Conduct a Mock Inspection in Preparation for an Audit
Eric Henry, Senior Quality Systems and Compliance Advisor, FDA and Life Science Practice, King & Spalding
9:15 - 10:00 ET
Select Between Knowledge Exchange Sessions (29-32)
29
Optimize Process Performance — Implement an Effective Quality Monitoring System
Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.
30
Conduct Remote Virtual Factory Acceptance Testing (FAT)
Donncha Nagle, Commissioning, Qualification & Validation Lead, Jacobs Engineering Group; and Researcher, TU Dublin
31
Leverage Digital Validation for Streamlined Risk-Based Testing
Dori Gonzalez-Acevedo, VP of Strategic Solutions, Tx3 Services
32
Learn How to Use Risk in Change Control Processes
Roque Redondo, VP Automation and Business Development USA Operations, mirus
10:00 ET
Exhibitor Showroom and Refreshment Break
10:30 - 12:00 ET
Select Between Knowledge Exchange Sessions (33-36)
33
Critical Utility Qualification and Environmental Monitoring Performance Qualification
Elizabeth Brockson, Senior Validation Specialist, CAI
34
Apply Quality by Design (QbD) for all Validation Types — QbD for All
Steve Thompson, Director Industry Solutions, ValGenesis
35
What to Do When Things Go Wrong — Implement an Effective CAPA Program
Shannon Chesterfield, Senior Director of Consulting, Azzur Group
36
Mastering the Critical Elements of a Quality Risk Management (QRM) Program
Chip Bennett, Associate Director, Global C&Q, SME, CQV Program Development, CAI
12:00 ET
Grab & Go Lunch and Think Tank Sessions
1:30 - 3:00 ET
Select Between Knowledge Exchange Sessions (37-40)
37
Personnel Training — Hiring People that Make Validation Great
Mark Cheshire, Business Development Manager, H&A Scientific
38
Use Validation Sampling Plans for Critical Decisions
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
39
Analytical Method Validation — What Quality and Process Professionals Need to Know
Kim Huynh-Ba, Managing Director, Pharmalytik LLC; Adjunct Professor, Regulatory Compliance, Illinois Institute of Technology (IIT)
40
Change Control - Conduct System Criticality and Impact Assessments
Alan Golden, MS, Principal, Design Quality Consultants, LLC
3:00 ET
Exhibitor Showroom and Refreshment Break
3:15 - 4:45 ET
Select Between Knowledge Exchange Sessions (41-44)
41
Assay Transfer, Qualification, Validation — Are We Living in a ‘Land of Confusion’?
Douglas B. Brown, Ph.D., Senior Scientist and Manager, Charles River
42
Qualification of Temperature Mapping and Storage Chambers
Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
43
Validation and Change Control — Null Hypothesis Significant Testing
Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care
4:45 ET
Close of Conference
VALIDATION & GMP UNIVERSITY
August 23rd – 25th
Join KENX for hands-on training for engineering, quality, C&Q and validation professionals within the pharmaceutical, biotech, medical device and related industries. Participants can 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.
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
135 E Kings Highway
3rd Floor
Haddonfield, NJ 08033
Email: info@kenx.org
Phone: 858 649 3251