Course description
Certified Investigator Training- Virtual Training
This course covers all aspects of pharmaceutical investigations from defining and investigating the problem using root cause analysis tools to writing up the investigation and determining the corrective and preventive actions (CAPAs) using the CAPA hierarchy and CAPA effectiveness.
This course is suitable if you investigate incidents, approve deviations or if you work in quality control and perform out- of-specification investigations. The training will be delivered via an instructor-led virtual classroom over four days. On completion, participants can provide three of their investigations to NSF for an expert, independent assessment of the thoroughness of the investigation and the clarity of the written report. (To maintain confidentiality, these investigations may be redacted.)
This course consists of four virtual instructor-led sessions that will run at 8.00am to 12.00pm EST, convenient for delegates from the US and other timezones.
Outcome / Qualification etc.
Key Learning Objectives
At the end of this pharmaceutical investigator training, delegates will know and understand:
- Critical steps when investigating incidents
- Pharmaceutical root cause analysis tools
- The CAPA hierarchy
- Types of investigations, complaints, recalls, out-of-specification (OOS) and out-of-trend (OOT) investigations
- How to write up a clear and concise investigation
Training Course Content
Course Outline
- Introduction to investigations, defining the problem, organizing and analysing data
- Anatomy of a problem (error-chain), active vs. latent, problem-solving tools, facilitation skills
- Recording the investigation, decision-making, developing CAPAs, CAPA effectiveness, CAPA hierarchy
- Deviation trending
- Types of investigations, complaints, recalls, OOS/OOT
Course delivery details
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Discounts
Multiple delegate discounts apply. Discounts offered to NHS staff, regulators and charities.