An Insight into FDA Inspections Training

The Understanding FDA Audits Training Course can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

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.

• Management responsibility
  • 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
• Being prepared
  • 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
  • The Audit Co-ordinator
  • Documentary requirements
  • Handling sensitive information
  • Consistency in responses
  • Terminating the audit
• Post 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

This course can be delivered to a group of up to 12 delegates at your premises or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.

ITS’ Regulatory Compliance Services’ Manager, Elizabeth Vaughan, has developed extensive knowledge of this specialist area from over 30 years’ industry experience working with Sanofi, Bristol Myers Squibb, Diomed Developments and Vifor Pharma UK. Elizabeth has worked in quality roles within the laboratory and pharmaceutical industry, and gained extensive experience in global quality systems and regulatory affairs, as well as ISO 13485, ISO 9001 and cGMP compliance. Throughout her career, she has been responsible for sharing her knowledge through the design and delivery of a range of training courses for production personnel including Good Manufacturing Practice, Change Control, Deviation Management, Electronic Record Compliance, Validation and Management of API Suppliers/Manufacturers. Elizabeth also has extensive experience in providing quality and GMP training to improve the performance of site quality managers.

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