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The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness!
The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
E-books: US and EU regulations
GMP translations (FR, SE, DK)
Search tool and document library. Find your way in regulations, guides and other reference documents.
Pharmaceutical and Biopharmaceutical industry
Standard operating procedures (SOPs) are a regulatory requirement but frequently, they aren’t as useful as they could – or should – be. Poorly written procedures make training more difficult and contribute to performance errors. This course is aimed at those who write, review, and approve procedures. It provides a tool and method that will help writers efficiently create clear, understandable procedures that are written at the right level of detail. The course includes structured activities where participants write sections of a procedure and then give and receive feedback from other learners. The final activity is for participants to write or revise a procedure that they use (or could use) in their work area.
Provide a five-step process so you can more efficiently write procedures that are clear, at the right level of detail, and a help to the person performing the task.
Given your experiences, identify some of the typical deficiencies that are found in SOPs.
List five steps used to write procedures.
Identify the most difficult challenge a procedure writer faces.
Discuss how checklists can be used to support performing a task in accordance with a procedure.
Given a procedure with deficiencies, identify ways to improve that procedure.
Given a data form, collect information that is essential in a procedure.
Given a task and an SOP development worksheet, write a procedure that has the appropriate level of detail for the user.
Operations, laboratory, technical, and quality personnel who write, review, approve, or contribute to SOPs.
Feedback from participants:(4.0 of 5) |
Course No:5109 |
Instructors: |
Next course:Contact us for information. |
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
(4.0 of 5)