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
BONUS! Two Optional Pre-conference Workshop
- Controlling Contamination in Pharmaceutical Water Systems
- Environmental Monitoring for Non-sterile Environments
PLUS! This event is co-located with:
CLEANING VALIDATION & CRITICAL CLEANING PROCESSES
At Microbiology University
June 20-22, 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of Annex 1 as it applies to the sterile environment and FDA’s Quality Consideration in Non-Sterile Drug Manufacturing Draft Guidance, and flurry of regulatory guidance, the time has never been greater to ensure you have procedures mastered to comply with compliance authorities.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
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.
