RQAP re-registration units: 1 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.
DescriptionThis course will cover the full life-cycle of controlled process documents - from creation through archival. Topics will also include responsibilities, training, and non-compliance. Attendees should be prepared to bring examples of questions relating to SOPs (controlled process documents) and SOP management.
ObjectivesAt the end of the course, the participants shall be able to:
- Understand the purpose and benefit of effective SOPs
- Understand the critical role of SOPs in Quality Documentation systems
- How to write a concise, unambiguous SOP for its intended purpose
- Define clear responsibilities to promote action and closure within the document
- Training requirements
- Manage revisions, nonconformance and deviations from a current SOP
- Difference between GCP/GLP/GMP
Target AudienceAnyone who is responsible for life cycle and compliance of these key components of the Quality Management System. This course is applicable to all; GMP, GCP, GLP, and GVP. This course is applicable for beginners as well as experienced personnel.
Agenda- Understand the purpose and benefit of effective SOPs
- Understand the critical role of SOPs in Quality Documentation systems
- How to write a concise, unambiguous SOP for its intended purpose
- Define clear responsibilities to promote action and closure within the document
- Training requirements
- Manage revisions, nonconformance and deviations from a current SOP
- Difference between GCP/GLP/GMP
Class will include team exercises