UCC Adult courses

(Bio) Pharma Processing - PG Cert

About This Course

Fact File

  • Title

    (Bio) Pharma Processing

  • Code

    PCBPP

  • College

    Adult Continuing Education, Medicine and Health

  • Duration

    6-7 months

  • Teaching Mode

    Part-Time

  • Qualifications

    PG Cert

  • NFQ Level

    Level 9

  • NFQ Award Title

    Minor

  • Fees

    €3000 See Fees and Costs for full details.

  • Entry Requirements

    A candidate must have obtained at least a Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8). See Requirements for full details.

  • Closing Date

    12th September 2022

  • Next Intake

    September 2022

  • Venue

    UCC

  • Start Date

    September 2022

Course Outline

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 and training sessions are delivered in the advanced laboratory-scale processing facilities in the School of Pharmacy, University College Cork and the Cork Education and Training Board facilities in Carrigaline. Career coaching and job readiness skills are provided via the ‘Transitioning into the Workplace and Placement’ module that is optionally available for recent graduates, those interested in career changes or re-engaging with recruitment processes. 


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). For the 2019/2020 programme the classroom/practical/site visits are scheduled for Fridays 9.30a.m - 5pm.

MODULES

Students will complete 30 credits as follows:

PF6603 Introduction to the Principle of Formulation and Dosage Form Design (5 credits)
PF6605 Microbiology and Sterile (Bio) Pharmaceutical Processes (5 credits)
PF6607 Pharmaceutical Process Design and Verification (5 Credits)
PF6609 GXP – Regulatory and Best Practice Standards in the (Bio)Pharmaceutical Industry (5 credits) 
PF6610 BioPharmaceutical Technology and Processes (10 credits)

Optional Module: PF6615 Transitioning into the Workplace and Placement (5 credits)

This optional module will be offered to students (subject to approval of the programme director) looking to transition into the workplace as follows (i.e. those classified as jobseekers or returners). PF6615 is assessed on a pass/fail basis and is not counted toward the final award. The result obtained in PF6615 will be recorded on the student’s transcript.

 

Course Practicalities

Assessment methods vary across the programme modules. All modules are assessed using continuous assessment (eg. practicals reports, site visit reports, written assignments, and group projects), with the P6605 and PF6610 modules also containing formal end of semester examinations (1.5 hours). The optional PF6615 ‘Transitioning into the workplace and placement’ module is assessed on a Pass/Fail basis. PF6615 is not required for progression and is not counted toward the final Certificate award. The result obtained in PF6615 will be recorded on the student’s transcript.

Why Choose This Course

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 and the Cork Education and Training Board facilities in Carrigaline.
  • 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 Fridays only semester 1 and 2.
  • Career coaching and job readiness workshops.

Placement or Study Abroad Information

Suitable students will be provided with an optional 5 credit module PF6615 focused on  transitioning to the workplace which, where possible, will include a placement in a local company.

Requirements

A candidate must have obtained at least a Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8).

In exceptional cases applicants not meeting the above criteria will be considered for entry based on an interview and successfully demonstrating that they hold an equivalent professional qualification, or significant industrial experience relevant to the course.

All applicants whose first language is not English are expected to have a minimum IELTS score of 6.5, with no individual section lower than 6.5. 

Fees and Costs

€3,000 for full programme
€700 per standalone 5 credit module

For further information on fees and financial supports please click here.

 

How Do I Apply

During your online application you will be required to upload the following documents:

  • Application Statement
  • Birth Cert or Passport
  • Passport Photograph 
  • Curriculum Vitae
  • English Language Test Report [if applicable]
  • Transcripts [if applicable]

 

 

Year 1 Modules

  • PF6603: Introduction to the Principles of Formulation and Dosage Form Design (5 credits)
    Scientific principles of dosage form design. Physicochemical properties of drugs. Overview of routes of drug administration. Introduction to the formulation and manufacture of conventional dosage forms.
  • PF6605: 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.
  • 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.
  • PF6609: GxP - 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 GCP, GLP, GDocP, GDP, GSP and GRP. Regulatory considerations for designing and conducting clinical trials. Medical device regulations. Regulatory approval pathway for biosimilars and advanced therapy medicinal products.
  • PF6610: BioPharmaceutical Technology and Processes (10 credits)
    Introduction to pharmaceutical biotechnology. Principle and design of biological drugs. Vaccines. Recombinant therapeutic proteins. Introduction to antibodies and their derivatives (Including humanized monoclonals). Upstream and downstream processes in the manufacture of biopharmaceutical products. Choice and management of production cell line. Bioreactor design principles and practice. Expression, purification, characterization and analysis of protein drugs. 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.
  • PF6615: Transitioning into the Workplace and Placement (5 credits)
    Job Readiness; Exploring self-awareness and setting realistic career objectives; Understanding your strengths, development needs, opportunities and threats; Developing a career-management strategy and identifying career goals; Creative job-hunting both online and offline; Written applications, CVs and interview preparation; Implementing career plans; Industry relevant, problem base case studies designed to provide realistic insight into the issues faced by Biopharma and Pharmachem organisations. 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.

Year 2 Modules

Year 3 Modules

Year 4 Modules

For queries regarding course content or timetables please contact

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