In House training Course

Handling API Manufacturing Deviations

Duration - (2.5 – 3 Hours)

This presentation was developed to help participants to determine what actions are needed to build a formal system for handling Critical Deviations in the API industry.

The key to effective handling of manufacturing deviations is the ability to maintain full regulatory and cGMP compliance while focusing on CRITICAL deviations. 

During this seminar, participants will learn about Critical Deviation Management (CDM), how to identify which control parameters are critical to intermediate and API quality and how to develop the results into a Knowledge Management system which is both cost effective and compliant and may be used to develop improved Process Flow.

The main issues of this session are:

• Key aspects of knowledge management
• Building the framework of Critical Deviation Management
• The key roles of Manufacturing and Quality Assurance staff in implementation and governance of CDM.
• Avoiding pitfalls of implementation

Part I:     Deviations - Reactive Handling vs. Proactive Management 

• Traditional reactive handling of manufacturing deviations
• Know what is critical and use it proactively
• Focus QA effort where it is most needed
• Full involvement of manufacturing management in deviation handling

 Part II:    Building the Basis of Proactive Deviation Management

• Key aspects of knowledge management
• Building the framework of Critical Deviation Management

Workshop:    Developing CDM Documentation

Part III:     CDM Inplemenatation and Maintenance

• Avoiding pitfalls of implementation
• Key systems for maintenance of compliance

Part IV:      Continuing Governance of Critical Deviation Management

• Periodic review – benefits for Annual Product Reviews
• Critical Deviation Management within the quality system
• Spin-offs for other compliance areas, e.g. instrument maintenance

 Part V:        Question and Answer Session.

Bonus documents

• Example of Process Rationale Document
• Example of Troubleshooting Guide

This training could be used in conjunction with other courses available, please contact us if you would like help in putting a programme together

Course Speaker

Dr David Inglis