Trainees will learn the necessary skills to be able to plan, perform, report and improve in relation to all audits and inspections. They will also learn how to consult appropriately with outside regulatory bodies and to represent your organisation during inspections and whilst auditing your suppliers, in a professional, thorough and fair manner.
Plan and prepare effectively for internal cGMP auditing within the Pharmaceutical Quality System.
Learn how to:
- Gather objective evidence, through effective interviewing, observation, sampling and note taking.
- Analyse and interpret information to determine conformance with requirements, effectiveness, and, areas for improvement.
- Report the audit, including writing valid, factual and value-adding audit reports.
- Undertake audit follow-up activities, including evaluating the effectiveness of corrective action.
Who should attend
- Quality Managers and those with internal auditing / self-inspection responsibilities across all departments.
- Those who want to pursue a career as an Auditor.
As places are limited, book early to avoid disappointment.
Location: Virtual Classroom
Cancellations
Places cancelled within ten working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
https://futureinpharmaceuticals.com/
Course Objectives
By the end of the course participants will be able to:
- Describe the purpose of a quality management system (QMS) and explain the eight principles of quality management.
- Explain the purpose, content and interrelationship of cGMPs, ISO 9000, and ISO 19011.
- Understand the structure and key requirements of cGMPs.
- Interpret requirements of cGMPs in the context of an audit.
- Describe the role of internal audit in the maintenance and improvement of management systems.
- Understand the different types of audits.
- Describe the roles and responsibilities of auditors and lead auditors.
- Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to:
a) plan and prepare effectively
b) gather objective evidence, through effective interviewing,
observation, sampling and note taking.
c) analyse and interpret information to determine conformance with requirements, effectiveness, and areas for improvement.
- Report the audit, including writing valid, factual and value-adding audit reports.
- Undertake audit follow-up activities, including evaluating the effectiveness of corrective action.
- Professionally consult with external auditors.
During the two days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.