AGENDA
12:00 ET
Exhibitor Showroom and Virtual Platform Open House
12: 45 ET
Chairman's Opening Remarks
1:00 - 1:45 ET
FDA Releases New Draft Guidance on Quality Considerations in Non-sterile Drug Manufacturing - What This Means for You
Ziva Abraham, CEO, Microrite, Inc.
1:45 - 2:30 ET
Using Quality Risk Management (QRM) to Prevent Contamination
Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Isreal
2:45 - 3:30 ET
Around the World in 80 Ways - Harmonised Programs, Processes and Technology Enterprise-Wide
Miriam Guest, Associate Principal Scientist, AstraZeneca (Invited)
3:30 ET
Exhibitor Showroom and Afternoon Stretch
4:00 - 4:30 ET
Overcome Top Challenges in Cleanroom Management, Environmental Monitoring and Cleaning Validation - Insight from the Front Line
Dawn Marshall, Senior Director Global Sterility Assurance, Sanofi Pasteur
4:30 - 5:00 ET
Human Behavior - Understand the Impact and Reduce the Risk
Chip Bennett, Associate Director, Global C&Q, CAI
5:00 ET
Networking Welcome Reception
7:15 ET
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 ET
Preparing for and Handling Inspections - Ensure Your Processes are Ever-Ready
Kimberley Buytaert-Hoefen, Ph.D., Director of Regulatory Services, Azzur Group, former FDA Investigator
7:55 - 8:35 ET
Develop and Implement a Risk-based Non-sterile Program
Elizabeth Brockson, MPH, VPH, Associate Director, Global Quality Control, CAI
7:55 - 8:35 ET
Cleaning Procedures - Understand and Control Variability
Joe Cagnassola, Validation Consultant; Formerly Principal Validation Engineer, Alcon
8:45 - 10:15 ET
Practical Implementation of the Contamination Control Strategy (CCS)
Ziva Abraham, CEO, Microrite, Inc.
8:45 - 10:15 ET
Establising a Meaningful Environmental Monitoring Program
David W. Vincent, B.Sc., MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
8:45 - 10:15 ET
Cleaning Validation Program Design - A Risk-based Lifecycle Approach
Matthew Jackson, Head of Quality & Compliance, Torbay Pharmaceuticals
10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 ET
Exhibitor Showroom and Think Tank Sessions
10:45 - 11:25 ET
Autoclave Qualification in Support of Steam Sterilization Validation
Chip Bennett, Associate Director, Global C&Q, SME, CQV Program, CAI
10:45 - 11:25 ET
Data Trending and Reporting for EM Programs in Controlled Environments
Joseph McCall, SM (NRCM), Director, QA Technical Services, ADMA Biologics
10:45 - 11:25 ET
Cleaning Re-Validation - Discover the Reasons and How to Do It
Fred Ohsiek, Senior Validation Manager, Ecolab Life Sciences
11:35 - 12:15 ET
Trending as Part of a Contamination Control Strategy
Susan Cleary B.CS, EMBA – Direct Product Development, Novatek International
11:35 - 1215 ET
Data Deviation Investigations and Root Cause Analysis
Joscelyn Bowersock, Therapeutics Implementation Lead and Solution Architect, L7 Informatics
11:35 - 12:15 ET
Understanding Soils and Residue - Understand the Importance of Cleaning Agent Selection
Beth Kroeger, Technical Services Manager, STERIS Life Sciences
12:15 ET
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 ET
Microbial Control - Implement a Proactive Approach to Reduce Risk
David W. Vincent, B.Sc., MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
12:45 - 1:25 ET
Calculate and Set Alert / Action Levels for Environmental Monitoring
Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Isreal
12:45 - 1:25 ET
Product and Equipment Grouping Considerations for Cleaning Validation
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
1:35 -3:05 ET
Contamination Control Strategy for Aseptic Environments - Program Development, Validation, Maintenance
Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Isreal
1:35 -3:05 ET
Developing Proactive Corrective Action Preventive (CAPA) Programs
Elizabeth Brockson, MPH, VPH, Associate Director, Global Quality Control, CAI
1:35 -3:05 ET
Hot Topics in Cleaning - Stainless Steel Equipment Maintenance and Air Liquid Interface Rings
Beth Kroeger, Technical Services Manager, STERIS Life Sciences
3:05 ET
Exhibitor Showroom and Afternoon Stretch
3:30 - 5:00 ET
Design, Construction, Classification, and Requirements
Morgan Polen, Cleanroom, Particulate and Airflow Expert, Microrite, Inc.
3:30 - 5:00 ET
HVAC Systems - Risk-based Qualification, Validation, and Maintenance
Matthew Jackson, Head of Quality & Compliance, Torbay Pharmaceuticals
3:30 - 5:00 ET
Cleaning Validation Continuous Monitoring Best Practice
Joe Cagnassola, Validation Consultant; Formerly Principal Validation Engineer, Alcon
5:00 ET
Close of Day Two
7:15 ET
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 ET
Air Velocity Measurements and Correlation to Smoke Studies for Aseptic Operations
Morgan Polen, Cleanroom Contamination Control Expert, Microrite, Inc.
7:55 - 8:35 ET
Conduct an EM Risk Assessment - An Implementation Example
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
7:55 - 8:35 ET
Learn What Risk Tools to Use and How to Use Them in Cleaning Validation
Chip Bennett, Associate Director, Global C&Q, SME, CQV Program, CAI
8:45 - 10:15 ET
Disinfectant Efficacy Testing – Methodology and Approach to Validation
Madison Hoal, Global Technical Consultant, Ecolab Life Sciences
8:45 - 10:15 ET
Conduct an Audit of Your Environmental Monitoring Porgram
Joseph McCall, SM (NRCM), Director, QA Technical Services, ADMA Biologics
8:45 - 10:15 ET
Documentation BET Practice - Protocols, Reports, SOPs, Templates, and Master Plans
Chip Bennett, Associate Director, Global C&Q, CAI
10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 ET
Media Fills in Validation - Demonstrate Sterile Media without Contamination
Cecil Runyon, Senior Director of Laboratory Services, and Laura Farrell, Quality Manager, Azzur Labs
10:45 - 11:25 ET
High-Potency APIs - The Impact on Validation/Verification/EM Monitoring for Cleanrooms
Kenneth Pierce, Ph.D., Technical SME Europe, Cleaning Science and Cleaning Validation, Hyde Engineering + Consulting
10:45 - 11:25 ET
Using Analytical Test Methods for Cleaning Validation
Seth Robinson, Technical Service Associate, STERIS
11:35 - 12:15 ET
Cleaning and Disinfection - The Details Matter
Ratul Saha, M.S. M.Sc., Ph.D., Director, Contamination Control, Seres Therapeutics
11:35 - 12:15 ET
Control Microbial Contamination in Pharmaceutical Water Systems
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
11:35 - 12:15 ET
Master the Practice of Visual Inspection
Jeffrey Gerstein
12:15 ET
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 ET
Case Studies in Cleanroom Operations - Micrococcus, Deinococcus, and Cutibacterium
Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
12:45 - 1:25 ET
Determine Optimal Sampling Sites for Qualification Studies
Dawn Marshall, Senior Director Global Sterility Assurance, Sanofi Pasteur
12:45 - 1:25 ET
Cleaning Validation – Critical Process Parameters and Critical Quality Attributes in Practical Use
Jeffrey Gerstein, New England General Director, Compliance, ips
1:35 - 2:45 ET
Develop a Risk Assessment Method for Fungal Contamination
Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
1:35 - 2:45 ET
Conducting Bioburden Assessments as Part of Quality Control
Cindy Duhigg, Global Validation Steward, Alcon Laboratories
1:35 - 2:45 ET
Quantify Detergent or Cleaning Agent Residues
Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
3:05 ET
Exhibitor Showroom and Afternoon Stretch
3:05 -3:30
Women Leading Validation Breakout Group
3:30 - 4:15 ET
Understand Personnel Requirements and Implement Effective Training Programs
Shelley Preslar, President & COO, Azzur Training Center at Azzur Group
4:15 ET
Close of Day Three
SPONSORS
Cleanroom Validation, Disinfection & Environmental Monitoring
April 27-29, 2022
Attend Virtually or in Philadelphia, PA
With the impending changes of Annex 1 as it applies the sterile environment and FDA’s Quality Consideration in Non-Sterile Drug Manufacturing Draft Guidance, the time has never been greater to ensure you have procedures mastered to comply with regulatory authorities. KENX’s hybrid conference showcases those paving the way in best practices in cleanroom qualification, disinfection, contamination control, environmental monitoring and more. As a bonus, the event is co-located with Cleaning Validation and Critical Cleaning Processes and has over 40 tutorials to enhance your professional development.
Join KENX at industry’s cleanroom validation event of the year! Whether you’re in QA, validation, or engineering; a novice or advanced professional; or, attending in-person or online, this is your chance to network with over 200 of like-minded colleagues in the FDA-regulated environment.
BEST IN CLASS PROCEDURES SHOWCASED IN THESE CRITICAL AREAS
Cleanroom Validation and Disinfection
- Design, Construction, Classification, and Requirements
- Personnel Requirements and Training Programs
- Qualification and Monitoring Best Practice
- Bioburden Assessments as Part of Quality Control
- Microbial Control – Proactive Approach to Reduce Risk
- Optimal Sampling Sites for Qualification Studies
- Aseptic Program Development, Validation, and Maintenance
- Media Fills in Validation
- Training Strategy Playbook for Cleaning and Disinfection
Environmental Monitoring
- Quality Considerations in Non-sterile Drug Manufacturing – FDA’s Draft Guidance
- Risk-based Non-sterile Program Implementation
- Enterprise EM Program Design – An Implementation Case Study
- Data Deviation Investigations and Root Cause Analysis
- Data Trending and Reporting and Alert / Action Levels
- HVAC Systems – Risk-based Qualification, Validation, and Maintenance
- Rapid Microbial Methods – Success and Challenges
- Biofluorescence Particle Counters and Mold Studies
- Microbial Control in Pharmaceutical Water Systems
- Endotoxin Testing vs. Environmental Monitoring
Cleaning Validation & Critical Cleaning Processes
- Process Design – A Lifecycle Approach Case Study
- Risk Analysis in Cross Contamination
- Soils and Residue Selection
- Equipment Grouping Considerations
- Documentation Best Practice – Protocols, Reports, SOPs, Templates, and Master Plans
- Acceptance Criteria and Health Limits
- Risk-based Continuous Monitoring and Gowning Checklist
- Critical Process Parameters and Critical Quality Attributes
- Disinfectant/Detergent or Cleaning Agent Residues and How to Quantify
- Stainless Steel Equipment Maintenance
- Visual Inspection
Personnel in the Following Environments Should Attend:
- Validation/Qualification
- QA/QC
- Manufacturing and Laboratory
- Microbiology, Science and Chemistry
- R&D
- Environmental Control
- Regulatory Affairs and Compliance
This event is also appropriate for business development, sales and marketing managers with products and services to the FDA-regulated drug, biologics and device manufacturing and laboratory environments.
Hotel Venue
Wyndham Philadelphia Historic District, 400 Arch St, Philadelphia, PA 19106
[tribe_tickets]
TESTIMONIALS
“My first KENX event: very impressed! Great information and even better presenters.”
AD of Engineering, American Laboratories
“Very organized and informative. Excellent speakers.”
– Senior Process Scientist, Bristol-Myers Squibb
“The excellent speakers and range of relevant, timely topics that KENX offers through their conferences is second to none!”
-Global Validation Steward, Alcon Laboratories
“This is the first time I am attending a Virtual Conference, Love how interactive it is and also the Whova app is great.”
CSV Manager, Meitheal Pharmaceuticals, Inc.
“Great presentations, speakers, and interaction by both onsite and remote participants. Whova has been the best virtual conference platform I’ve experienced over the past few years.”
-ISO IT CSV and SQA Manager, AmerisourceBergen
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.