Across the many diverse business functions within the pharmaceutical industry, the requirement to perform audits of key service and material suppliers has become a significant driver for regulatory compliance and corporate governance. A successful audit relies on both the technical ability and the soft skills of the auditor(s).This 6 day course covers many of the technical and nontechnical aspects of pharmaceutical auditing and incorporates the skills needed for audits of GMP, GCP, GVP, GDP and API. The final two days give attendees a chance to experience practical elements of on-site auditing. The course is divided into one block of 4 days of lectures and 2 days of practical auditing experience. Delegates can choose to attend all six days or just particular days that are specific to their requirements. However to attend the site visits on the final two days, it is necessary that delegates first complete days 1-4.

 

Part 1: Behavioural Training: Basic Auditor Skills; Intermediate Skills; Guidelines for efficient Audits; Conflict Resolution.

Part 2: General Pharmaceutical Quality Aspects including GDP; Temperature mapping, monitoring and cold chain, Pest control and General GDP Deficiencies; Training, Documentation; QP release concept; Contract Manufacture and Analysis; Recalls, Anti-counterfeit measures, Computerised Systems; Regulatory Affairs - Marketing Authorisation obligations; Self Inspection.

Part 3: APIs, Non-sterile pharmaceuticals, Quality Control and specialised items: Active Pharmaceutical Ingredients; Solid and semi-solid dosage forms; Qualification - IQ, OQ, PQ, Computerised Systems; Quality Control, Analytical validation, Chromotograhpy; Risk Management, Process Validation; Cleaning Validation; Technical transfer.

Part 4: Sterile pharmaceuticals and Biotechnology: Microbiological principles; Methods of sterilisation; Aseptic Processing; Media fills; HVACs, environmental monitoring; Autoclaves Fo, Steam in place; Parametric release; Upstream and downstream processing; Audit preparation.

Part 5: GMP audit covering Warehousing, Primary Packaging of solid dose products, Validation documentation, QMS fundamentals.

Part 6: GMP audit of a Biologics facility, covering dispensing, innoculation, fermentation, downstream processing, Quality Control Laboratory, clean utilities (Air handling/WFI).