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 Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

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