The Understanding FDA Audits (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 audits
  • 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 audit
  • Types of audit
  • 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
  • Use of action planning through internal auditing
  • Improving management processes for compliance
  • Individual/team action plan for workplace integration of learning

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›