This course provides helpful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOP's. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOP's play in achieving the required level of compliance and quality.
The course material is presented by means of slides, handouts and participation of the attendees through discussion and individual/group exercises.
Note: Participants may bring an SOP related to their work for the workshop exercise on day two.
The workshop emphasises practical issues such as:
• The benefits of SOP's
• The logical approach to defining and writing the procedure section of the SOP
• Writing SOP's as part of a team
• Critiquing an example of a badly written SOP
The course provides ample opportunities for group discussions and hands on exercises. It enables participants to gain the skills and knowledge necessary to meet the expectations of regulatory agencies.
The course material is presented by means of slides, handouts and participation of the attendees through discussion and individual/group exercises.
Note: Participants may bring an SOP related to their work for the workshop exercise on day two.
The workshop emphasises practical issues such as:
• The benefits of SOP's
• The logical approach to defining and writing the procedure section of the SOP
• Writing SOP's as part of a team
• Critiquing an example of a badly written SOP
The course provides ample opportunities for group discussions and hands on exercises. It enables participants to gain the skills and knowledge necessary to meet the expectations of regulatory agencies.
