Practical Approach to Managing Deviations (1/2 day)

Aims and Objectives
A recent industry survey highlighted that the #1 cause of loss of pharmaceutical productivity was the ineffective management of deviations. This workshop provides participants with current approaches to effective deviation management and the opportunity to work through practical examples.

Learning outcomes and benefits

On successful completion of this course, participants should be able to:

• Analyse and revise their company deviation management system for improvement
• Complete process deviations to minimise productivity losses
• Classify deviations based on risk to compliance and product integrity
• Structure deviation trend analyses
• Link significant deviations to the CAPA system

Suitability

The course is suitable for all supervisors and managers required to handle GMP-related deviations, for example:

• Release for Supply/Marketing Authorization Officers
• Compliance, Quality Assurance and Quality Control personnel
• Operations and related managers and supervisors

While the case studies are pharmaceutical related, the principles of deviation management equally apply to device and biotechnology manufacturers.

Participant's notes, case studies and certificates of successful completion will be provided.