DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Regulatory Requirements and Principles for Cleaning Validation" conference to their offering.
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.
Who Should Attend:
- Senior quality managers
- Quality professionals
- Production supervisors
- Validation engineers
- Process owners
- Quality engineers
- Quality auditors
Day 1 Schedule:
Lecture 1: FDA Requirements and Industry Standard Practices
Lecture 2: How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
Lecture 3: How to Develop a Cleaning Validation Policy/Program
Lecture 4: How to Implement a Robust Cleaning Validation Plan
Day 2 Schedule:
Lecture 1: Laboratory Issues in Cleaning
Lecture 2: Microbiological aspects of a cleaning validation program for manufacturing equipment
Lecture 3: Keys to Cleaning Validation Maintenance ? Remaining Compliant
Lecture 4: Current FDA concerns about validation of cleaning processes
For more information about this conference visit http://www.researchandmarkets.com/research/mfnfh2/regulatory