Computer Systems Validation &
Software Assurance University
AGENDA
12:00 PT
Exhibitor Showroom and Virtual Platform Open House
1:15 PT
Chairperson’s Opening Remarks
1:30 - 2:00 PT
Stay Up To Speed with FDA's Computer Software Assurance Initiative
Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA; Senthil Gurumoothi, Senior Industry Specialist, AWS Healthcare and Life Sciences: Ken Shitamoto Senior Director, IT, Gilead Sciences; Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group
2:00 - 2:30 PT
The Interrelationship Between Data Integrity and CSA
Scott Cady, Senior IT Quality & Compliance Consultant, Azzur Group
2:30 - 3:00 PT
Remote Inspections During COVID and Beyond
Alton Johnson, Pharmaceutical Consultant
3:00 PT
Exhibitor Showroom and Afternoon Stretch
3:30 - 4:00 PT
Critical Thinking and the CSA Movement — Rethinking Your Approach to Technology
Ken Shitamoto, Senior Director, IT,Gilead Sciences
4:00 - 4:30 PT
Sustain and Build a Quality Culture in Today's Realities
Ajaz Hussain, Ph.D., Advisor, ValGenesis, Inc., Formerly U.S. FDA
4:40 - 5:00 PT
Understand the Impact of the Digitalization Revolution to CSV
Senthil Gurumoothi, Senior Industry Specialist,AWS Healthcare and Life Sciences
5:00 PT
Game Night - Trivia Welcome Reception
7:15 PT
Exhibitor Showroom and Lite Breakfast
7:55 - 8:35 PT
Take a Risk-based Approach to Audit Trail Reviews
Joseph Zec, Associate Director, Data Systems, R&D Quality, Takeda Pharmaceuticals
7:55 - 8:35 PT
Building and Managing a Data Integrity Program
John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI
8:45 - 10:15 PT
mplement a CSV Program Aligned with CSA
Steve Thompson, Director of Industry Solutions, ValGenesis, Inc.
8:45 - 10:15 PT
Inspection Readiness – Implementing a Mock Audit Program
Leslie Lighton-Humphreys, IT CSV & SQA Manager, AmerisourceBergen
8:45 - 10:15 PT
ModernizeYour Data Integrity Program — New Insight from the Front Line
Matthew LaPierre, Data Integrity Specialist, Jackson Scott Consulting
10:15 PT
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 PT
Modernize Risk Management in Software Testing
Ido Raz, Chief Executive Officer, Validify
10:45 - 11:25 PT
Goal Setting for CSV - In Search of Tension - Lessons from a Rubber Band
Mark Cheshire, Business Development Manager, H&A Scientific, Inc.
10:45 - 11:25 PT
How to Implement Risk Management in Data Integrity
Patrick Mains, Principal Quality Engineer, Genentech
11:35 - 12:15 PT
Best in Class Documentation Using Checklists, SOPs, and Templates
Esra Guven, Manager, Computer Systems Validation, Global Information Services, Apotex Inc.
11:35 - 12:15 PT
Tips for Transitioning Current CSV Program to Align with CSA
Lelia Scott, Senior Director, Global Process Owner CSV, Bristol Myers Squibb
11:35 - 12:15 PT
Auditing Data Flows for Integrity and Compliance
Stephen R Ferrell, CISA CRISC CDPSE - Managing Director, CompliancePath
12:15 PT
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 PT
Develop a Strategy to Transition to Paperless Validation
Joseph Zec, Associate Director, Data Systems, R&D Quality, Takeda Pharmaceuticals
12:45 - 1:25 PT
Implement Risk Management in Cloud-based Platforms
Laurent Saugrin, Senior Staff Technical Program Manager, Dexcom
12:45 - 1:25 PT
Digital Validation – What Is It and Why Is It Important?
Dori Gonzalez-Acevedo, VP of Strategic Solutions, Tx3 Services
1:35 - 3:05 PT
Develop a Corporate Training Program for CSV/SA Best Practice Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics, a Nestle Health Sciences Company; Bryan Ennis, CEO, BTR
Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics, a Nestle Health Sciences Company; Bryan Ennis, CEO, BTR
1:35 - 3:05 PT
Cybersecurity - Best Practices to Protect Data Governance Irving Bruckstein, Advisory Board, Azzur Group
Irving Bruckstein, Advisory Board, Azzur Group
1:35 - 3:05 PT
Validating Pharma 4.0 Platforms for Smart Manufacturing Chinmoy Roy, Senior Industry Consultant, ValGenesis, Inc.
Chinmoy Roy, Senior Industry Consultant, ValGenesis, Inc.
3:05 PT
Exhibitor Showroom and Afternoon Stretch
3:30 - 5:00 PT
Control Risk for Computer Systems End-of-Life (Retire/Decommissioning) Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic
Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic
3:30 - 5:00 PT
Spreadsheet Validation Do’s and Don’ts
Clark Davies, Senior Software Quality Engineer, Abbott
3:30 - 5:00 PT
Kosal Keo, Founder & Chief Product Officer, BTR
5:00 PT
Close of Day Two
7:15 PT
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 PT
CSA Office Hours - Lessons Learned from the Front Line
Senthil Gurumoothi, Senior Industry Specialist, AWS Healthcare and Life Sciences; Ken Shitamoto Senior Director, IT, Gilead Sciences
8:45 - 10:15 PT
Conduct Risk-based Impact Assessments of Computer Systems
Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic
8:45 - 10:15 PT
Identify and Mitigate Gaps in CSV / SA Programs
Carlos L. Pereira, Regional Manager of U.S. Midwest and Canada, VTI Life Sciences
8:45 - 10:15 PT
Machine Learning and AI - An Effective Validation Approach
Steve Thompson, Director of Industry Solutions, ValGenesis, Inc.
8:45 - 10:15 PT
Enable Continuous Delivery of Software in Regulated Environments Byron Mattingly, Ph.D., Software Division Chair, American Society for Qualit
Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality
10:15 - 10:45 PT
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 PT
Quality Agreements for SaaS Systems
Geetanjali Abbi, Computer System Validation and Compliance, Alkermes
10:45 - 11:25 PT
System Configuration and Change Management – Too Much or Not Enough?
Dhruvin Patel, Manager of Quality Management Systems, INSMED
11:35 - 12:15 PT
Modernize Periodic Reviews of Computer Systems and Software Platforms
John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI
11:35 - 12:15 PT
Validation Community of Practice – Enabling Alignment and Collaboration Between Divisions
Leslie Lighton-Humphreys, IT CSV & SQA Manager, AmerisourceBergen
11:35 - 12:15 PT
Corrective Action in Data Integrity Lapses - Develop a Roadmap
Chinmoy Roy, Senior Industry Consultant, ValGenesis, Inc.
12:15 PT
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 PT
Qualification and Verification of Data Migration to Hosted Cloud Environments
Laurent Saugrin, Senior Staff Technical Program Manager, Dexcom
12:45 - 1:25 PT
Senior Level Master Class - Discover Solutions to Top Challenges
Lelia Scott, Senior Director, Global Process Owner CSV, Bristol Myers Squibb
1:35 - 2:45 PT
Managing Global Infrastructures and Data Centers
Stephen R Ferrell, CISA CRISC CDPSE - Managing Director, CompliancePath
1:35 - 2:45 PT
Documentation Best Practice for CSV and DI Compliance
Stephen J Cook, VP – Validation and Compliance, and Kristan Buchholz, Compliance Lead, Compliance Group, Inc.
1:35 - 2:45 PT
Create and Use a Checklist for Conducting a GAMP®5 Assessment
Raul Soto, Senior Principal Engineer,Johnson & Johnson Vision Care
3:05 PT
Exhibitor Showroom and Afternoon Stretch
3:30 - 4:15 PT
How Much Validation is Enough?
Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, and Stephen J Cook, VP – Validation and Compliance, Compliance Group, Inc.
3:30 - 4:15 PT
Effective Data Integrity Processes for Paper and Hybrid Systems
Dhruvin Patel, Manager of Quality Management Systems, INSMED
3:30 - 4:15 PT
Overcome Validation and Data Integrity Challenges of GXP Mobile Apps
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
COMPUTER SYSTEMS VALIDATION & SOFTWARE ASSURANCE UNIVERSITY
December 6th – 8th
Take Advantage of Early Bird pricing through October 29th!
With FDA’s heightened focus on Software Assurance and Data Integrity – Computer Systems Validation has taken on a new movement initiated by regulatory authorities. In fact, FDA has taken the lead with a proposed guidance on Computer Software Assurance and is asking firms to rethink their approach. With that said, the challenges remain high in our rapidly changing environment. In fact, inspectors continue to find serious findings such as – 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.
Choose from Over 40+ Tutorials Addressing Today’s Top Challenges
COMPUTER SYSTEMS VALIDATION AND SOFTWARE ASSURANCE
- Critical Thinking and the CSA Movement – Rethinking Your Approach to Your Program
- Sustain and Build a Quality Culture in Today’s Realities
- Learn Machine Learning and AI Validation Strategies
- Modernize Risk Management in Software Testing
- Implement Risk Management in Cloud-based Platforms
- Design and Qualify Spreadsheets for Use in cGXP Environments
- Modernize the Periodic Review Process
- Enable Continuous Delivery of Software and Regulated Environments
- Validation Community of Practice – Effective Collaboration Across CSV Teams
- Managing Global Infrastructures and Data Centers
- Implement Effective System Configuration and Change Management Processes
- Validate Mobile Applications
- Create and Use a Checklist for Conducting a GAMP®5 Assessment
DON’T MISS THIS CRITICAL UPDATE
Stay Up To Speed with FDA’s Computer Software Assurance Initiative:
Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA
Senthil Gurumoothi, Senior Industry Specialist, AWS Healthcare and Life Sciences
Ken Shitamoto Senior Director, IT Gilead Sciences
Khaled Moussally, Executive Vice President Quality – Clients & Regulatory Relations, Compliance Group
PLUS! A SPECIAL FOCUS ON
DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS
- The Interrelationship Between Data Integrity and CSA
- Build and Manage a Data Integrity Program
- Construct of a Program from the Ground Up
- Auditing Data Flows for Integrity and Compliance
- Implement an Effective Audit Trail Review Process
- Corrective Action in Data Integrity Lapses – Develop a Roadmap
- Implement a CAPA Process – What to Do When Things Go Wrong
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, paperless validation platforms, and validation consultant services.
Faculty
BIOPHARMACEUTICAL MANUFACTURING
UNIVERSITY
AGENDA
11:30 PT
Registration & Exhibitor Showroom and Virtual Platform Open House
1:00 - 1:15 PT
Chairman’s Opening Remarks
1:15 - 1:45 PT
Examining Next Generation Biopharmaceutical Manufacturing
David W. Vincent, MPH, PhD, CEO, VTI Life Sciences
1:45 - 2:30 PT
Discovering how Covid-19 has Changed Biopharmaceutical Manufacturing Forever Delivery
Ravi Samavedam, President & COO, Azzur Cleanrooms on Demand Dan Dernbach, VP of Operations at Azzur Cleanrooms on Demand, Azzur Group"
2:30 - 3:00 PT
Smart Manufacturing and Contamination Control Strategies for Bio-Pharmaceuticals as ATMPs
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
3:00 - 3:30 PT
Exhibitor Showroom and Think Tank Sessions
3:45 - 4:15 PT
Using Process Analytical Technology (PAT) Tools in Biopharmaceutical & Pharmaceutical Manufacturing
Venkatesh Srinivasan, Vice President, Global MSAT-BT, Bayer
3:45 - 4:15 PT
Creating the Biopharma Workforce of the Future
Emily Moran, VP, Viral Vector Manufacturing, The Center for Breakthrough Medicines
4:15 - 4:45 PT
Advances and Trends in Aseptic Fill / Finish for Targeted Therapy Products
Keith Dodson, Vice President of GlobalBusiness Development, Automated Systems of Tacoma (AST)
4:15 - 4:45 PT
4 Tips for Enhancing Trust with Contract Organizations for Increased Efficiency and long-lasting Relationships
Luiz Barberini, Head of External Manufacturing Operations, Bayer
4:45 - 5:30 PT
Data Integrity and Biopharmaceutical Manufacturing
Dominic Mancini, Senior Director MSAT, OrganaBio, LLC
Marc Diament, CEO & Founder, Integral Biometrics
Roque Redondo, Senior Technical Consultant, PharmEng Technology
5:30 - 7:30 PT
Game Night - Trivia Welcome Reception
8:00 - 8:45 PT
Registration & Breakfast
8:45 - 9:00 PT
Opening Remarks
9:00 - 9:50 PT
Creating an Agile Culture to Be Ready to Adapt to New Innovative Ways of Working
Brent Gendleman, Innovation Lead IT Advisory Services, Azzur
Jordyne Blaise, Director of Diversity, Equity & Inclusion, Bluebirdbio
9:50 - 10:35 PT
The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 During Covid-19
Jon Thompson, Principal Consultant, CAI
10:00 - 10:25 PT
In-Silico Process Development, Data Management and Data Access on CMC Acceleration
Umay Saplakoglu, Chief Digital Officer, Global General Manager, Cytiva
10.35 - 11:00 PT
Networking break
11:00 - 11:45 PT
Challenges to Designing and Constructing Optimal Facilities for the Production of Cell & Gene Therapies
Ravi Samavedam, President & COO, Azzur Cleanrooms on Demand
Dan Dernbach, VP of Operations at Azzur Cleanrooms on Demand, Azzur Group
Emily Moran, VP, Viral Vector Manufacturing, The Center for Breakthrough Medicines
11:00 - 11:45 PT
Remote Monitoring and Big Data Advance Upstream Automation and on-line monitoring in BioPharma Manufacturing
11:45 - 12:30 PT
Challenges & Solutions to Distributing and Tracking of Off-the-Shelf Cell Therapies
Amanda Conerty, Sr. Director of CMC, Artiva Biotherapeutics
11:45 - 12:30 PT
Building a Modern Manufacturing Enterprise on the Foundation of IoT, Data-Driven Decision-Making and Digital Technologies
Bryan Ennis, CEO, BTR
12:30 - 1:40 PT
Lunch
1:40 - 2:15 PT
Improving the Supply Chain for the Biopharma Industry – What Covid-19 Vaccine Production is Teaching Us
Kelly Smeltzer, Senior Principal Consultant, CAI
2:15 - 2:55 PT
Regulatory Considerations for Expedited Programs
Kimberley Buytaert-Hoefen, Director of Regulatory Affairs, Azzur
Eric Good, Director of Compliance, ProPharma Group
2:15 - 2:55PT
Cloud Does Not Bite! How to Enhance the Pharma, Biotech and Life Science Industry by Implementing Modern IT Solutions with a Compliant Regulatory Control Framework.
Agata Mizera, Governance, Risk and Compliance Lead, Capgemini
2:15 - 2:55PT
Enabling Successful Process Validation in Biopharmaceutical Manufacturing
Rahul Rajan Kaushik, VP, Protein/Antibody Process Development & Manufacturing, Fibrogen
2:55 - 3:25 PT
Exhibitor Showroom and Think Tank Sessions
3:25 - 3:40 PT
Networking break
3:40 - 4:15 PT
Smart Collaboration – R&D and Manufacturing Breaking Down Barriers for Better Efficiencies
Priya Baraniak | Vice President, Corporate Development | OrganaBio
4:15 - 4:45 PT
Digital Tools in Bioprocess Design and Optimisation
Maria Papathanasiou | Lecturer | Imperial College London
4:45 - 5:15 PT
Partnering for Success – Collaborations between Industry and Academia
Emily Hopewell, Director, Cell and Gene Therapy Manufacturing, Indiana University
5:15 - 5:30 PT
Closing Remarks for the Day
5:30 - 7:30 PT
Cocktail Reception
8:00 - 8:55 PT
Registration & Breakfast
8:55 - 9:00 PT
Opening Remarks
9:00 - 9:30 PT
Reflecting on the Growing Momentum for Biosimilars in the US
Antonio Moreira, Vice Provost for Academic Affairs and Professor of Chemical, Biochemical and Environmental Engineering, University of Maryland, Baltimore County (UMBC)
9:30 - 10:00 PT
Future-Proofing Life Sciences for the Regulated-Cloud
Bryan Ennis, CEO, BTR
10:00 - 10:25 PT
In-Silico Process Development, Data Management and Data Access on CMC Acceleration
Umay Saplakoglu, Chief Digital Officer, Global General Manager, Cytiva
10:25 - 10:45PT
Networking break
10:45 - 11:15 PT
Leveraging Flexible Networks, Cutting-Edge Innovation in a Quality Culture
10:45 - 11:15 PT
Realizing the Paradigm Shift to a Smarter Manufacturing Process
Chor Sing Tan | Strategy Manager Growth Initiatives | Cytiva
11:15 - 11:45 PT
The Road to Digital Transformation in Biopharma: Moving from Change Management to Enterprise Transformation for Bioprocessing 4.0
Rosalind Beasley, VP Digital Innovation, Dot Compliance Inc
11:15 - 11:45 PT
Unleashing the Value of Quality by Design Through Continuous Process Verification, Manufacturing Anomaly Capture & AI-enabled Proactive Quality Response
Stephen McCarthy, VP, Digital Innovation, Honeywell Sparta Systems
11:45 - 12:30 PT
Exhibitor Showroom and Think Tank Sessions
12:30 - 1:45 PT
Networking Luncheon
1:45 - 2:15 PT
Supply Chain Resiliency – Manage Through Disruption
Dominic Mancini, Senior Director, MSAT, OrganaBio
2:15 - 2:45PT
A Packaging Engineer – Luxury or Necessity?
Jan Gates, President/Advisor Packaging Engineer, PackWise Consulting
2:45 - 3:30 PT
Increasing Efficiencies and Reduced Development Timelines in Bioprocess Development and Manufacturing through Hybrid Modeling
Mark Duerkop, CEO, Novasign GmbH
3:30 - 3:45 PT
Closing Remarks
3:45 PT
End of Biopharmaceutical Manufacturing University
BIOPHARMACEUTICAL MANUFACTURING UNIVERSITY
June 6th – 8th, 2022
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 June 6-8 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
FACULTY
Cleanroom Validation, Disinfection &
Environmental Monitoring
Cleanroom Validation, Disinfection & Environmental Monitoring
February 21-23, 2022
Attend Virtually or in Philadelphia, PA
Many companies spend exorbitant amount of money and time on the qualification of cleanrooms and the validation of product manufactured within. KENX is proud to present a one-stop-shop for professionals tasked with the contamination control and disinfection, cleanroom design, environmental monitoring and cleaning validation practices at their facility. This hybrid conference showcases those paving the way in best practices in cleaning validation, cleanroom qualification, disinfection, contamination control, environmental monitoring and more. You have the opportunity to choose between 3 distinct tracks in Cleanroom Operations and Disinfection, Cleaning Validation and Critical Cleaning Processes, or Environmental Monitoring. You can also experience all 3 tracks by registering for our Cleaning Passport. This conference delivers more the 30 tutorials in:
Cleanroom Operations and Disinfection
- Design and construction – Optimize performance and compliance
- Implementation of a holistic, risk-based program
- Development and validation of disinfectant efficacy
- Create a playbook for operators
- Determine optimal sampling sited
- Create a risk-based culture and define roles and responsibilities
- Identify contamination risks and conduct an assessment
- Reduce validation timelines and cost
Cleaning Validation & Critical Cleaning Processes
- Establish acceptance criteria and set health limits
- Learn latest trends and overcome top challenges
- Discover risk-based approaches to cleaning monitoring and manufacturing
- Create a Cleaning Validation Master Plan – Key elements for success
- Validation of analytical methods used in cleaning
- Selection of cleaning agents and parameters
- Implement a personnel training program and gowning procedure
- Maintain stainless steel equipment in sterile environments
Environmental Monitoring
- Investigations of alert/action level excursions
- Trend data and analyze results
- Develop a robust, risk-based program from the ground Up
- Implement a continuous monitoring program
- Qualify water, clean steam and process gasses
- Establish sampling sites and execute plans based on risk
- Best documentation strategies for critical information
- Develop an approach for non-sterile environments
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.
135 E Kings Highway
3rd Floor
Haddonfield, NJ 08033
Email: info@kenx.org
Phone: 858 649 3251