| Code | PF5801 |
|---|---|
| Teaching Mode | Part-Time |
| Qualifications | CPD Module |
| NFQ Level | N/A |
| Fees | €3250 See Fees and Costs for full details. |
| Closing Date | 3 May 2024 |
| Next Intake | May 2024 |
| Venue | UCC and auditing facility Dublin |
| Start Date | 13 May 2024 |
Course Outline
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).
Course Practicalities
This course will run for four days in the School of Pharmacy UCC and two days in a training facility in Dublin.
Assessment:
To pass the module, candidates must complete an online assessment.
Who Teaches This Course:
Stan O’Neill
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.
Dairine Dempsey
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.
Paula Dillon
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.
Denice Coakley
An ex-inspector with the IMB/HPRA as a GMP inspector, leading and performing GMP inspections throughout the world. She has experience in the inspection of sterile, non-sterile, biotech and IMP manufacturing facilities as well as contract laboratories, gamma irradiation, ETO and compounding facilities. She was also involved in the training of new inspectors and presented at various HPRA information days and QP forums.
Dearbhla Byrne
She has worked in the Pharma and Biopharma industry for over 20 years across different departments and held roles in QA, QC, QP, NPI and validation. An ex-GMP Inspector with the Health Products Regulatory Agency (HPRA). A registered subject matter expert for biotechnology with the European Medicines Agency. Experience in the inspection of sterile, non-sterile, biotech, IMP and ATMP manufacturing facilities as well as contract laboratories, gamma irradiation, ETO and compounding facilities.
Requirements
- 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
€3250 - Please pay fees to the Compliance Group click here for further details.
How To Apply
Applications are currently being accepted for this course.