Regulatory Requirements and Principles for Cleaning Validation - Research and Markets

DUBLIN--()--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

Agenda:

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

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceutical Manufacturing

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceutical Manufacturing