An Insight into FDA Inspections (1 Day) Training course provides an insight for learners into how the FDA audits a healthcare manufacturing company.
Subsequent investigation delves into the potential effects on an organisation when non-compliance to current Good Manufacturing Practice (cGMP) is identified and what those potential consequences may be.
The cycle of the audit is investigated including identifying and training the team through to completion and any follow-up activities.
Senior management commitment
SOPs and policies
Handling 'hot topics'
Use of internal auditing - improving quality
Schedule of internal audits
Mock FDA inspections
Results and actions
Developing an audit plan
Use of reference folder
Key people involved in audits and their responsibilities
The role of the Inspection Co-ordinator
Preparing staff for an inspsection
Types of FDA inspections
Roles and responsibilities
Briefing and training
Responding to inspectors
The use of disciplined behaviour
The Audit Co-ordinator
Handling sensitive information
Consistency in responses
Terminating the audit
Responses to FDA inspections
Use of action planning through internal auditing
Improving management processes for compliance
Individual/team action plan for workplace integration of learning