About This Course
CPD Module in Pharmaceutical Auditing
N/A See Fees and Costs for full details.
Applicants must be currently employed in the pharmaceutical sector and hold a BSc or equivalent. See Requirements for full details.
UCC Campus and Dublin Training Facility
Tuesday 14th May 2019
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).
This course will run for three days in School of Pharmacy UCC and two days the following week in a training facility in Dublin.
To pass the module, candidates must complete an MCQ exam (at the end of the course at UCC) and submit a 1,500 essay on Pharmaceutical auditing.
Who Teaches This Course:
After qualifying as a Pharmacist, Stan spent over five years working in the pharmaceutical industry in Regulatory Affairs, Marketing and Quality Assurance (QP) and then joined the Irish Medicines Board (now the HPRA) for a period of ten years. In his capacity as a Senior Inspector, he performed GMP inspections throughout the world, represented Ireland at European level for the negotiation of standards of inspection for medicinal products and trained Inspectors at Irish, European and International levels.
A qualified pharmacist and ex –Senior regulator in the area of pharmacovigilance, herbal medicines and pharmaceutical assessment with the Irish Medicines Board (now the HPRA).
Dairine has over 10 years experience in the field of medicines regulation and has represented Ireland at European and International level.
An ex-Inspector with the Irish Medicines Board and over 9 years experience in the regulation of controlled drugs and GDP, Paula has represented Ireland at European and International level, including as a member of the GDP Drafting Group which was responsible for establishing the new GDP Guidelines. Paula is now the Head of Quality, Aquilant Specialist Healthcare Services.
- Applicants must be currently employed in the pharmaceutical sector and hold a BSc or equivalent.
- Consideration may be given to other applicants with suitable equivalent professional qualifications and significant industrial experience (greater than 5 years relevant experience in the pharmaceutical industry).
Fees and Costs
How Do I Apply
Applications are currently being accepted for this course.