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The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
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Pharmaceutical and Biopharmaceutical industry
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.
(4.4 of 5)
Provide participants a model for a well-written investigation report and enhance their skills at writing and reviewing such reports.
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.
Operations, laboratory, technical, and quality personnel who write, review, approve, or contribute to incident, deviation, OOS or CAPA investigation reports.
Course No:5110 |
Instructors: |
Next course:April 16, 2013, Stockholm CANCELLED |
Course venue:- |
Agenda:9.00-17.00 (Registration 08.30-09.00) |
Price:€ 945 incl. course material, lunch and refreshments |
Language:English |
Discounts:For larger groups we can offer discounts based on case by case discussions, please contact for quotation. |
Cancellation policy for Compliance Seminars®:Registration is binding and when you have received our confirmation the following conditions are know 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 200 € (Euro). Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full. Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start.) In such circumstances course fees will be refunded, or granted to attend another course for the same value. |
Key2Compliance AB and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Tel: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com
