Define quality, quality and competitiveness. Quality costs as a driving force. Define quality assurance. Differentiate between Quality Control and Quality Assurance. Quality Culture and ethics. Regulatory bodies including the FDA, EMA, HPRA, EPA and HSA and their functions. Introduction to the Code of Federal Regulations, Eudralex and relevant international standards. The principles of GMP. The role of the employee in delivering quality products.

The importance of documentation, types of documents such as standard operating procedures, specifications, batch manufacturing records, deviation reports, validation poliecies, protocols and reports etc. Writing and controlling official procedures. Edition, numbers, revision numbers, document status. Control and distribution of documents. Storing, retrieving and updating documents. The change control process, types of change control. Preparation of GMP compliant documents. Compaints: management of complaints and using complaints as a means to improve systems and processes. Responsibilities of the manufacturer, pharmacovigilance, deviation management and CAPA. Introduction to Quality Risk Management.

Review of steps to ensure data is accountable, legible, contemporaneously recorded, original or tru copy and accurate.

Categories of audits and approaches to auditing. Analysis of the steps involved in auditing manufacturing environments. Audit reports and corrective actions. FDA/HPRA audits.

Laboratory Accreditation, Method Validation, LIMS, Calibration requirements, INAB, Comparison of ISO 17025 requirements and GLP requirements.

Identification of critical process parameters. Methods of monitoring processes. Process Analytical Technology. Product Release requirements, Real Time Release requirements.

The importance of training in controlled manufacturing environments. GMP requirements of training. Different training methods. Maintenance of training records.