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Bio Pharma Processing

The Postgraduate Certificate in (Bio)Pharma Processing is designed for graduates who wish to transition into employment in the (bio)Pharma sector. The part time course provides pharmacy, science or engineering graduates, as well as candidates who hold sufficient previous educational/professional experience, with a technical overview of current processing in Pharmaceutical and Biopharma sectors. The programme design provides participants with both a theoretical and practical understanding of the processes involved in drug substance and drug product manufacture. It is delivered part-time by a combination of online distance learning supported by classroom workshops, practicals and site visits. Practical sessions are delivered in the advanced laboratory-scale processing facilities in the School of Pharmacy, University College Cork. Career coaching and job readiness skills are provided via the 'Transitioning into the Workplace' module for recent graduates, those interested in career changes or re-engaging with recruitment processes.

The part-time programme provides participants with technical expertise for career progression in both the Biopharma-Pharmaceutical manufacturing sectors.

Key programme aspects include:

Hands-on practical experience of unit operations at lab scale facilities in the School of Pharmacy, University College Cork.

Practical application of the theory relating to pharmaceutical processing both Biopharma, Pharmchem and Drug Product.

Delivery online and in-classrooms allowing flexible contact hours; On-site teaching at UCC 2017/2018 Fridays only semester 1 and 2.

Career coaching and job readiness workshops.

Entry requirements

A candidate must have obtained at least Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8). Consideration will be given to other applicants with sufficient equivalent professional qualifications and significant industrial experience.

Duration

9 months

A typical workload for each module is as follows; Students will be expected to attend classroom workshops (UCC), practicals and site visits (approx. 30 hrs), undertake self-directed study in advance of classroom/practical sessions (approx. 30 hrs), continuous assessment assignments and/or prepare for end of semester exam (40 hours). Students are only required to attend classes at the university 1 day per week during each 12 week semester (Sept- Dec and Jan – April).

Further enquiries

Rachel O Farrell
rachel.ofarrell@ucc.ie
+353 (0)21 490 4706

https://www.ucc.ie/en/ace/

Dr. Eoin Fleming
j.fleming@ucc.ie
021-490-1679

Subjects taught

Year 1 Modules
PF6602: Transitioning into the workplace (5 credits)
The module is workshop based and involves significant interaction with UCC careers services, external career consultants and career coaching, culminating in the development of a personal action plan for students' transition into employment.

Positioning oneself for Job Readiness: (Exploring self-awareness and setting realistic career objectives; Understanding your strengths, development needs, opportunities and threats; Looking at role models and finding creative solutions to common job-hunting challenges; Developing a career-management strategy and maximising your reputation online).

Moving forward into employment: (Taking action by developing career goals and implementing them; Creative job-hunting both online and offline; Written applications, CVs and interview preparation; Implementing career plans.

Careers in the (Bio) Pharma industry: (Industry relevant case studies designed to give the student realistic insight into the issues faced by Biopharma and Pharmachem organisations. The case studies will be problem-based in an effort to help prepare the student in their future careers. This part of the module will involve industry experts and will introduce students to the principles of working in a regulated environment, and requirements for the continual validation of process and product.

PF6603: Introduction to the Design and Delivery of (Bio) Pharmaceutical Medicines (5 credits)
Introduction to drug delivery routes and drug delivery systems used for biopharmaceutical medicines. Basics of biological barriers to drug delivery. Physiochemical properties of drug substances and excipients. An overview of biopharmaceutical dosage formulation design and preparation: Pre-formulation design, common dosage forms; solutions, suspensions, delivery challenges, stability, excipient selection, pegylation. Parameters critical to product quality (aggregation) and relevant characterisation techniques. Routes of biopharmaceutical delivery: parenteral, pulmonary, transdermal.

PF6604: (Bio) Pharma Process Technology (5 credits)
An overview of fundamental unit operations (heat transfer, mass transfer, fluid dynamics). Downstream Processing (Filtration and Chromotography), Formulation Processes (Freezing/Thawing, Compounding, Pumping, Filling, Lyophilisation) and Packaging.

PF6605: Introduction to Microbiology and Sterile (Bio) Pharmaceutical Processes (5 credits)
Pharmaceutical microbiology: overview, practical aspects and applications in sterile (bio) pharmaceutical products. Microbiological culture media: types, manufacture and quality control. Bioburden determination. Environmental monitoring. Identification of sources and routes of contamination. Sterile processing and control. Sterilization and sterility assurance. Cleaning and disinfection. Water for (bio) pharmaceutical preparations. Aseptic processing. Cleanroom design and control. Barrier isolation technology. Sterile dosage form design and manufacture. QC testing for sterile products: sterility testing, particulate testing, pyrogen/endotoxin testing. Preservation of (bio) pharmaceutical products and antimicrobial efficacy testing.

PF6606: Pharmaceutical Biotechnology Processes (5 credits)
Introduction to pharmaceutical biotechnology. Principle and design of biological drugs. Recombinant therapeutic proteins.
Antibodies (humanized monoclonal) and antibody derivatives. Advanced gene therapy and nucleic acid targeting approaches. Upstream and downstream processes in the manufacture of biopharmaceutical products. Design and production of biosimilars. Choice and management of production cell line. Bioreactor design principles and practice. Expression, purification, characterisation and analysis of protein drugs.

PF6607: Pharmaceutical Process Design and Verification (5 credits)
Risk assessment and quality by design. Equipment requirements and finishes. Scope and types of validation strategies, DQ, IQ, OQ, PQ concepts, Commissioning, Process verification, Cleaning validation, Analytical validation, Process automation and validation of process control systems (GAMP). Continuous process verification.

PF6608: Placement (Postgraduate) (5 credits)
Students during placement will undertake duties associated with a full-time employee. Develop the skills necessary to integrate into a workforce e.g. communication, teamworking, problem solving, adaptability, reliability and punctuality. Establish positive working relations with colleagues, showing sensitivity to the needs of others and practicing confidentiality about the organisation and its employees and clients. Evaluate the working conditions with reference to hours of work, rate of pay, career development opportunities, etc.

PF6609: GxP - Introduction to Regulatory and Best Practice Standards in the (Bio) Pharmaceutical Industry (5 credits)
Introduction to regulatory affairs and (bio) pharmaceutical quality systems. Registration and licensing requirements for new medicinal products and facilities. An overview of cGMP requirements in the regulations. Selected topics on quality systems. Role and legal responsibilities of the Qualified Person. Pharmacovigilance and post marketing surveillance. Principles underpinning GDocP, GDP, GLP and GCP. Regulatory considerations for designing and conducting clinical trials. Medical device regulations. Regulatory approval pathway for biosimilars and advanced therapy medicinal products.

Assessment method

Assessment methods vary across the programme modules. The Placement and 'Transitioning into the workplace' modules are assessed by 100% continuous assessment. The placement is assessed on a Pass/Fail basis. For these modules continuous assessment examples include a Career development plan, Group project, Placement Portfolio (Placement Plan, Placement Journal, Review of Placement and Supervisor's Report). All other modules will be assessed by a combination of continuous assessment and end of semester written paper (1.5 hours). Continuous assessments examples include practical and site visit reports, written assignments and group projects.

Application date

Closing Date 30th August 2019

Course fee

€3,000 for full programme
€700 per standalone module

Enrolment and start dates

Start Date September 2019

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