• Regulatory Expectations for Cleaning Validation in the U.S. & European Union (EU)
• Cleaning of Potent Products – Current Issues and Regulatory Initiatives (EMEA, FDA)
• China and India – Current Global Quality Issues related to Cleaning
• How to develop Comprehensive Cleaning Programs
• Determining When to Clean and How long it Remains Clean
• Cleaning Validation using Manual, Semi-Automatic, and Automatic Cleaning Technologies
• Selection of Appropriate Cleaning Agents
• Selecting Analytical Methods for Detergent Residue Detection
• Sampling plans and Sampling Techniques - Hands-on Swabbing, Vial Handling, Instrument loading
• Handling Precursor and Degradant Molecules
• Establishing a Proper CIP Cleaning Cycle and Proper Mode of CIP Return
• Validation Issues with Static and Dynamic Spray Devices
• Principles of Equipment Design for Maximum Cleanability
• Swabbing Techniques for Non-specific and specific (TOC and HPLC/UV-Vis)
• Calculating Residue Limits that meet all necessary regulatory requirements
• Calculating Limits for Cleaning Validation and Identifying False Positives
• Setting Limits for Microbial Residues and Cleaning Agents (NOEL approach)
• Managing Failures during a Cleaning Program Implementation 
• Auditing Cleaning Validation Programs to Identifying Gaps and Weaknesses
• Performing Self-Assessment of Cleaning Master Plans, SOPs, Training,
• Recent Citations addressing the Most Common Failure Modes
• Implementing Risk-Based Approaches for Cleaning Validation Programs
  

This program is directed toward Directors, Managers, Supervisors, Coordinators and Associates in the Pharmaceutical, Biotech and allied industries in departments

• Validation, engineering and production staff whose responsibilities include cleaning and/or validation of the cleaning process
• QA and QC staff, at all levels of responsibility, who want to gain a comprehensive understanding of cleaning process requirements and rationale and to learn documentation requirements for demonstrating cleaning efficiency and validation
• R&D analytical and formulation staff who are responsible for development of suitable cleaning analytical methods and corresponding validation and development of formulation and manufacturing processes
• Regulatory affairs and compliance personnel who want a better understanding of the logistics of process cleaning regulatory requirements for cleaning validation
• Scientists or technical staff in government or academia who want to learn more about cleaning and cleaning validation
• Other personnel whose responsibilities involve:
  • Cleaning Validation
  • Quality Assurance
  • Quality Control
  • GMP/GLP Compliance
  • Production
  • Process Engineering
  • Regulatory Affairs
  • Research and Development
  • Raw Materials Testing
  • Product Development
  • Formulation
  • Manufacturing
  • Product Submission
• Documentation and Technical Writing