FDA Audits Training
Course Title: Understanding FDA Audits Training
Course Duration: 1 day
Course Aims: To provide an understanding and awareness of FDA audits.
Course Content:
  • 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
Course Dates: Understanding FDA Audits Training, 16th November 2007, Dublin, €558+VAT (£385+VAT) per learner (£452.38 inc. VAT).
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Understanding FDA Audits Training, 7th February 2008, Cardiff, £380+VAT per learner (£446.50 inc. VAT).
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Understanding FDA Audits Training, 7th May 2008, Cheshire, £380+VAT per learner (£446.50 inc. VAT).
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Understanding FDA Audits Training, 5th June 2008, Edinburgh, £380+VAT per learner (£446.50 inc. VAT).
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Understanding FDA Audits Training, 7th August 2008, Bristol, £380+VAT per learner (£446.50 inc. VAT).
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Understanding FDA Audits Training, 2nd October 2008, London, £399+VAT per learner (£468.83 inc. VAT).
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Understanding FDA Audits Training, 9th December 2008, Durham, £380+VAT per learner (£446.50 inc. VAT).
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GROUP BOOKING DISCOUNT - Book two place on an open course and receive the third place at half price.

Cost includes tuition, lunch and training materials. Download a printable version of the Booking Form and Terms and Conditions.
On-site Courses: This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.
Further Details: Request more information on this training course.
Related Courses: GAMP® 4 Training
GMP Fast Track Freshers Training
GMP Training for Managers
Understanding the Regulation 21 CFR Part 11 Training
Understanding Validation Training
Course Calendar: View Course Calendar
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