Regulatory Requirements and Principles for Cleaning Validation Course (Opfikon, Switzerland – March 8-9, 2018) – Research and Markets

Requirements and Principles for Cleaning Validation”
has been added to Research and Markets’ offering.

This two 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.

Attendance at 2 day seminar will be beneficial to personnel directly
involved in the development of cleaning procedures, cleaning validation
programs and plans. Additionally, those responsible for cleaning
validation protocols and execution activities, including validation and
laboratory personnel, as well as, beginning or seasoned operational
personnel who will eventually participate in such efforts, will find
this course particularly useful. This includes Analytical Method
Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate
with regulatory agency inspectors to rationalize or defend cleaning
validation programs will also benefit from attending this course. There
are no prerequisites for attending, but a basic knowledge of general
science and equipment cleaning processes is helpful.

Areas Covered in the Session:

  • Understand the importance and underlying principles of cleaning
    validation and the requirements to have adequate cleaning procedures
    for manufacturing equipment in contact with the product
  • Understand the FDA perspectives on cleaning validation and areas of
    concern during regulatory inspections
  • Be able to set up cleaning validation procedures, protocols and
    reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare and defend your own cleaning validation approach/program and
    avoid costly delays and/or rejections by regulatory agencies

For more information about this conference visit


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