About GMP Training
Good Manufacturing Practice (GMP) covers the quality and manufacturing practices required in regulated industries such as pharmaceuticals and medical devices. GMP is a regulatory practice, not an ISO standard, and GMP training is essential for organisations that implement and practice GMP. It is delivered at two levels:
Delivered by IAS with its sister organisation EAS, the Internal Auditor GMP course leads to a course-completion certificate.
What the GMP Internal Auditor Course Covers
The session concentrates on the practical knowledge needed to audit operations and processes effectively, including how to use standard operating procedures (SOPs) within your operation:
- GMP principles and the regulatory framework for pharmaceutical and medical-device manufacturing.
- Documentation and records, and standard operating procedures (SOPs).
- Premises, equipment, personnel, and hygiene controls.
- Production and process controls, and quality control.
- Deviation and change control, and corrective and preventive action (CAPA).
- Assessments and audits, self-inspection, and follow-up; preparing and managing a GMP internal audit.
Who Should Attend?
This course is ideal for anyone who needs the skills and knowledge to conduct a GMP internal audit or manage a team of auditors — including QA/QC staff, project managers, lab associates, and new hires in pharmaceutical or medical-device organisations.
Prerequisites
There is no mandatory requirement for previous experience in quality management systems; however, basic knowledge of GMP auditing is an advantage.
Duration & Delivery
The GMP Internal Auditor Training runs for one (1) day. It is a lecture-based seminar combined with interactive exercises to practice new skills, conducted at your location or at our auditor's offices.
Benefits of Attending
Attendees gain the ability to develop their own internal-auditing programme based on a unified framework and gain hands-on experience from experienced internal auditors who have performed many assessments.
How Do I Become a GMP Auditor?
Those who have been in the field for five (5) years or more and occupy a higher-level position can become GMP auditors. Typically, you start with internal audits and build confidence by undertaking document reviews as an investigator.
How to Enrol
To take up the course, contact us for details or email enquiry@iascertification.com.
