This course aims to develop contemporary understanding of both process and cleaning validation in order to comply with regulatory expectations. In addition, it reviews the objectives and standard practices. and provides practical directions on how to use quality risk management principles to prepare validation plans that meet current regulatory expectations.

GMP-operator-working-on-mixing-vessel

Content

  • The GMP reasons for process validation
  • Strategies for process validation that complies with cGMPs
  • Essentials of a process validation protocols
  • Requirements for re-validation and give examples of situations that would give rise to it
  • GMP reasons for cleaning validation
  • Strategies for cleaning validation that complies with cGMPs
  • Practical limits for cleaning residues
  • Essentials of a cleaning validation protocol

Participants

This course has been designed for validation professionals as well as those involved in approving process validation and cleaning validation plans and projects. It also applies to anyone interested in the latest trends and methodologies in process / cleaning validation that are rapidly becoming industry standards.

Format and Course Length

The 2-day course involves a lively mix of case studies / workshops and tutorial sessions. The delivery method is collaborative involving a small group and facilitator, which has been shown to enhance effective learning and critical thinking skills of participants. You will receive PDF copies of the training material and a Certificate of Attendance.

Possible Date

Singapore, November 2020.

Dates can be flexible and we encourage you to contact us with your needs so we can discuss how to help.

Refer to the Terms and Conditions