Compliance Seminars®

Writing Incident and Deviation Investigation Reports

Writing an investigation report is sometimes viewed as a “penalty” when something doesn’t go as planned or when an unwanted – or unforeseen – event occurs. From a quality perspective, these reports have the potential to contribute to product and process understanding and help prevent recurrences from occurring in the future.


This course is aimed at those who write, review, and approve incident and deviation investigation reports for laboratory, operations, and other GMP areas. The course identifies what national authorities and quality auditors are looking for in reports and provides a structured approach for doing investigations, identifying Corrective Actions and Preventive Actions (CAPAs), and writing sections of reports that are defendable, yet clear and concise.

The course includes activities where participants evaluate investigation reports and identify ways to improve them. The final activity is for participants to write an investigation report based on different case studies.

Course goal:

Provide participants a model for a well-written investigation report and enhance their skills at writing and reviewing such reports.

Objectives:

  • Identify four different audiences of investigation reports and what they are expecting to see in an investigation report.
  • Identify the different sections of an investigation report and what each section should include.
  • Discuss how investigation reports can contribute to product and process understanding throughout the lifecycle of a drug.
  • Describe and utilize tools that can be used to determine “root causes” of an incident.
  • Discuss options of what can be done when a definitive root cause cannot be identified.
  • Discuss how “human error” is not, in itself, a useful root cause.
  • Given an investigation report with deficiencies, identify ways to improve that report.
  • Given a case, determine the alignment of the root cause(s) and the specific immediate actions, corrective actions and preventive actions to be taken.
  • Given a case, write a self-contained summary for case.
  • Given a case, write an investigation report.
  • Given an investigation report, review it and provide suggestions for improvement.

Who should attend:

Operations, laboratory, technical, and quality personnel who write, review, approve, or contribute to incident, deviation, OOS or CAPA investigation reports.

Gate2GMP®

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Course facts

Course no:
5110
Industry:
Pharmaceuticals and Biopharmaceuticals

Level:
Intermediate
GMP region:
US and EU

Language:
English

Date, location and venue:
No planned sessions.

This course is offered in-house.
Click here for more info and inquiry form.


Time:
1 day
8.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
7 200 DKK (€ 965) incl. course material (pdf), lunch and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.

Discounts:
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.