This course provides an introduction to the functions of Quality Assurance (QA) and Quality Control (QC) in the effective and safe production and control of medicinal products.
Objectives
- Recognise how attention to manufacturing quality products reflects on daily operations
- Identify the role of QA in pharmaceutical manufacturing
- Recognise how companies use GMP rules to minimise errors in manufacturing
- Identify main roles & responsibilities of QC
- Recognise the key elements of a Pharmaceutical Quality System.
Topics and Content
- Introduction
- Objectives
- Reviews and assessment
- Overview
- Quality principles
- What do you think?
- What do the GMP rules state?
- Overview
- What is quality?
- Fundamental GMP rules
- Responsibility for quality
- Knowledge and behaviour
- Pharmaceutical Quality System (PQS)
- PQS model
- Key PQS elements
- Management responsibility
- Quality functions within a PQS
- Quality Assurance (QA)
- What do you think?
- What do the GMP rules state?
- Overview
- Vendor assurance
- Documents and records
- Traceability
- Training
- Internal audits / self-inspections
- Types of audits
- CAPA definitions
- CAPA systems
- CAPA phases
- Change management (change control)
- Deviations
- Release for supply
- Release for supply checks
- True or false?
- Vendor assurance is...
- Select all that apply for GMP compliant documents
- Good Manufacturing Practice (GMP)
- What do you think?
- What do the GMP rules state?
- Overview
- Scope of GMP rules
- Documentation and records
- Introduction to validation
- Cleaning validation (example)
- Process control
- Contamination control
- Which documentation provides information on whether or not a process remained in control?
- True or false?
- Select all options that need validating
- Quality Control (QC)
- What do you think?
- What do the GMP rules state?
- Overview
- QC responsibilities
- Good (Quality Control) Laboratory Practices
- Laboratory documentation system
- Sampling
- Reliable test methods
- Specifications
- Checking results
- Limitations
- Select all options that QC is responsible for
- Is there inherent risk in conclusions from sample results?
- Fill in the blanks
- Conclusion
- Summary
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel in any role to be clear on PQS compliance and understanding the roles, responsibilities and relationships between of QC, GMP and QA.
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.
