This course looks at GMP documentation (as a history of manufacturing from supplier to customer) across master instructions, SOPs, batch records, QC records and how to complete GMP records.
Objectives
- Recognise the importance of procedures
- Recognise the importance of record keeping
- Identify the possible consequences of not completing and certifying GMP documents
- Identify how to complete batch records and associated supporting documents
Topics and Content
- Introduction
- Objectives
- Reviews and assessment
- Requirements
- What do you think?
- What do the GMP rules state?
- Regulatory requirements
- GMP compliance
- Documentation and records
- Document features
- Document control
- Select true or false for each statement
- What is required as part of GMP batch documentation?
- Select all that apply
- GMP documentation
- What do you think?
- What do the GMP rules state?
- Types of documentation
- Specifications
- Inward goods
- Manufacturing formula, instructions and batch records
- Other production documentation
- Quality control (QC)
- Fill in the blanks
- How must batch records be completed?
- Select all that apply
- Record keeping
- What do you think?
- What do the GMP rules state?
- Importance of record keeping
- Completing records
- Which correction is correct?
- Select true or false for each statement
- Case study
- What do you think?
- What do the GMP rules state?
- Introduction
- Identify some documentation issues
- Tell the QA Director what you think
- Conclusion
- Summary
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel because good documentation and record keeping practices apply to all GMP operations.
Assessment / Certificate
There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.
A PDF Certificate is issued upon passing the quiz.
Duration
The course is expected to take approximately 1 hour.
Access
For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.
For individuals, you can buy now for $149 (ex GST) and your licence grants you access to the course for 30 days.
Contact us with any questions.
