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An Insight into FDA Inspections Training

TRAINING COURSE

An Insight into FDA Inspections Training

Duration: 1 day

Price: £690 +VAT Per Learner

Available Dates

If you would like to attend this course and it is not planned or full, please contact us or call us on 01642 222232 to make other arrangements.

Overview:

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.

Content:

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

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Home
Training
An Insight into FDA Inspections Training

TRAINING COURSE

An Insight into FDA Inspections Training

When:

Duration: 1 day

Price: £690 +VAT Per Learner

If you require onsite or venue-based training please contact us or call us on 01642 222232

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“Very good course, well presented with mix of media and experienced trainer. Good extra resources recommended.”

Depuy

“Excellent course. It was very informative and easy to apply to my current role.”

Sanofi

“Good overview of GAMP® 5.”

Bioquell

“Will be recommending it to my manager for colleagues.”

Bespak Europe

“Well planned and explained. Adapted to the people and industry attending.”

ECHA Microbiology

“Very educational and informative.”

Imperial College London

“I have a much clearer understanding of how the guidance works and implementation.”

Pall

“Very good overview of GAMP® 5 – its history, need and very crucial place within the pharmaceutical industry.”

GlaxoSmithKline

An Insight into FDA Inspections Training

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An Insight into FDA Inspections Training

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