Aims
To provide an introduction on auditing principles and practices, and to develop a broad understanding of the requirements and techniques for planning, conducting and reporting quality audits applicable to manufacturing systems for drugs, biologics and medical devices.
Outline Syllabus
- Critical role of quality audit in GMP compliance & improvement.
- Standards and guidelines for quality auditing
- GMP requirements for internal audit programs
- Techniques for auditing.
- Documents, records & data for effective audits.
- Utilisation of risk management in relation to prioritising audits and reporting of deficiencies.
Course Description
Companies manufacturing in the drugs, devices and biologics industry are expected to comply with all the applicable GMP requirements based on regulations, guidance documents, industry publications, professional interpretations and even customer expectations.
This course puts these into a logical perspective so that the participant can identify the correct GMP requirements unique to their company’s particular circumstances. The course also identifies common requirements of Quality Management and Key Quality System Elements that all companies would be expected to implement.
The course consists of a lively mix of presentations, group exercises, and discussions. Copies of all presentation slides and handouts will be provided.
Who Should Attend
The course is designed to service a wide range of participants from various disciplines within the drugs, devices or biologics industry. Participants considering working in these industries or those wishing to enhance their professional development and advancement in management are particularly encouraged to apply.
This course is specifically designed for participants who have prior knowledge in GMP compliance and Quality Assurance, or those considering working in the drugs, biologics and medical device.
Learning Outcomes
On successful completion of this module, the student will be able to:
- State the attributes of a competent auditor
- Discuss the intent and principles of systems and compliance auditing
- Identify audit standards and guidelines.
- Discuss the role of audits and CAPA in continuous improvement
