HYBRID CONFERENCE

VENUE

The DoubleTree by Hilton or attend virtually

237 s Broad Street, Philadelphia, Pennsylvania







CAI





CLEANING VALIDATION & CRITICAL CLEANING PROCESSES

At Microbiology University

August 21-23, 2022

Attend Virtually or in Philadelphia, PA

With the changes of Annex 1 as it applies to the sterile environment and FDA’s Quality Consideration in Non-Sterile Drug Manufacturing Draft Guidance, and flurry of regulatory guidance, the time has never been greater to ensure you have procedures mastered to comply with compliance authorities.  KENX’s hybrid conference showcases those paving the way in best practices in Cleaning Validation and Critical Cleaning Processes. As a bonus, the event is co-located with Contamination Control, Disinfection and Environmental Monitoring and has 35 tutorials to enhance your professional development.

BEST IN CLASS PROCEDURES SHOWCASED IN THESE CRITICAL AREAS

CLEANING VALIDATION & CRITICAL CLEANING PROCESSES

  • Understanding the Different Approaches between Process Cleaning and Facility Cleaning
  • Case Study – Develop, Implement, and Maintain a Risk-based Cleaning Validation
  • Establishing Critical Process Parameters, Acceptance Criteria and Health Limits
  • Common Gaps in Cleaning Validation and Their Solutions
  • Analytical Approach for Implementation of Visual Inspection
  • How to Develop and Apply the Maco Limits with Automation
  • Validate Aseptic Processing through Effective Media Fill Tests
  • Cleaning Process Development from Lab Bench to Full Scale – Lean Six Sigma Case Study
  • Soils and Residue Selection
  • Using DOE for Cleaning Process Development – Cleaning Agent Selection to Cleaning Parameter Determination
  • Hot Topics – Equipment Grouping, Gowning, Stainless Steel, Cross Contamination
  • Strategies for Maintenance and Continuous Improvement
  • Using Statistics in Cleaning Process Development and Validation
  • Create Your Custom Cleaning Validation Audit Checklist
  • Reduce Cleaning Process Waste – Cleaning Cycle Efficiency and Environmental Footprint – How Much Can You Save?
  • Understanding the Cost and Reducing Risks of Human Errors

Don’t Miss Our Pre-Sale Deadline Through June 9th ($995)

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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.
Temple Track - Cleaning & GMP Bundle Ticket
Get access to both Cleaning and GMP University AND all the pre/post conference workshops for just $1990!
$ 3,580.00 $ 1,990.00 $1,990.00
Unlimited
Cleaning & GMP Bundle Ticket
Get access to both Cleaning and GMP University AND all the pre/post conference workshops for just $1990!
$ 3,580.00 $ 1,990.00 $1,990.00
Unlimited
Cleaning University - Pre-sale Single Admission - 2023
$ 1,395.00 $ 995.00 $995.00
Unlimited
Cleaning University - Pre-sale Team Discount - 2023
Buy 4 get a 5th FREE
$ 1,116.00 $ 796.00 $796.00
Unlimited
Temple Track - Cleaning University - Pre-sale Single Admission - 2023
$ 1,395.00 $ 995.00 $995.00
Unlimited
Post-Conference Workshop
Attend one of the following workshops: 1) Controlling Contamination in Pharmaceutical Water Systems presented by: Susan B. Cleary, B.Cs, M.B.A., Director of Product Development, Novatek International or 2) Environmental Monitoring for Non-Sterile Environments Presented by: Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Israel
$ 395.00 $ 295.00 $295.00
Unlimited

CHOOSE BETWEEN 2 POST-CONFERENCE WORKSHOPS!

PRE-SALE PRICE $295 | REGULAR PRICE $395


1) Controlling Contamination in Pharmaceutical Water Systems
Susan B. Cleary, B.Cs, M.B.A., Director of Product Development, Novatek International
OR
2) Environmental Monitoring for Non-Sterile Environments
Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Israel

PLUS! This event is co-located with:

CONTAMINATION CONTROL & DISINFECTION

  • EU GMP Annex 1 – The Impact on Cleaning and Disinfection
  • Risk-based Contamination Control Strategy – Cleanroom Design and Operation
  • Disinfectant Efficacy Studies – Misperceptions, Why’s, When’s and How’s
  • Understand what FDA Thinking is about in Non-Sterile Dosage Forms from a Contamination Control Perspective
  • Hot Topics – Container Closure Systems, Rapid Methods, Bioburden Assessments
  • Why the Little Things Matter in a Microbiology QC Laboratory and the Potential Catastrophe of Not Managing Them Properly

ENVIRONMENTAL MONITORING

  • A Risk Based Approach to Developing and Maintaining an Environmental Monitoring Program
  • Investigation of Alert/Action Level Excursions
  • Risk Based EM Sampling Strategy – Using the Process Risk Control to Determine EM Sampling Strategy
  • Data Trending and Analysis – Digitalize Your EM Program
  • Conduct a Gap Analysis of Your EM Program – Identify Top Challenges and Solutions for Them
  • Commissioning and Qualification of Clean Utilities
  • Design of an Environmental Monitoring Performance Qualification Program
  • Handling Data Deviation Investigations and Root Cause Analysis
  • Documentation Best Practice – Protocols, Reports, SOPs, Templates, and Master Plans

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.

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.
Temple Track - Cleaning & GMP Bundle Ticket
Get access to both Cleaning and GMP University AND all the pre/post conference workshops for just $1990!
$ 3,580.00 $ 1,990.00 $1,990.00
Unlimited
Cleaning & GMP Bundle Ticket
Get access to both Cleaning and GMP University AND all the pre/post conference workshops for just $1990!
$ 3,580.00 $ 1,990.00 $1,990.00
Unlimited
Cleaning University - Pre-sale Single Admission - 2023
$ 1,395.00 $ 995.00 $995.00
Unlimited
Cleaning University - Pre-sale Team Discount - 2023
Buy 4 get a 5th FREE
$ 1,116.00 $ 796.00 $796.00
Unlimited
Temple Track - Cleaning University - Pre-sale Single Admission - 2023
$ 1,395.00 $ 995.00 $995.00
Unlimited
Post-Conference Workshop
Attend one of the following workshops: 1) Controlling Contamination in Pharmaceutical Water Systems presented by: Susan B. Cleary, B.Cs, M.B.A., Director of Product Development, Novatek International or 2) Environmental Monitoring for Non-Sterile Environments Presented by: Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Israel
$ 395.00 $ 295.00 $295.00
Unlimited