| Course Name |
Pharmaceutical Business Operations |
| Course Provider |
Innopharma Labs Ltd |
| Course Code |
113055 (Assigned by Qualifax. Not an official code) |
| Course Type |
Lifelong Learning |
| Qualifications |
| Award Name | NFQ Classification | Awarding Body | NFQ Level |
| Degree - Ordinary Bachelor (Level 7 NFQ)
More info...
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Major |
QQI |
Level 7 NFQ |
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| Apply To |
Course provider |
| Attendance Options |
Part time, Evening, Online or Distance, Daytime, Weekend, Blended |
| Location (Districts) |
Sandyford, Cork City |
| Enrolment and Start Dates Comment |
Intake: September 2022 |
| Application Date |
Expand+Our admissions team are on hand to assist you with your application and answer any questions you may have on the course.
Students who wish to apply to this course should follow the following application process.
Step 1: Enquire through the form...
Hide-Our admissions team are on hand to assist you with your application and answer any questions you may have on the course.
Students who wish to apply to this course should follow the following application process.
Step 1: Enquire through the form at the top right of this page
Step 2: A member of our team will be in contact through phone or email
Step 3: If you are deemed to be eligible for the course, you will be sent an application form by email. You MUST fill in this application form and attach all necessary *documents (CV, ID, Transcripts, etc.)
Step 4: On submission of the completed application form and all documentation, your application will be sent to the associated department for final approval. You will receive an e-mail confirming your place on the programme. (Note: This process can take up to one week particularly during busy admission periods.)
*We accept scanned documents in a pdf format. Pictures of documents are not accepted.
**For those who are applying for Springboard or HCI funding, you will be directed to fill out an additional application form on the Springboard website, this is to confirm your eligibility to receive funding
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| Duration |
This course is delivered through blended learning, 2 evenings per week online and up to 2 Saturdays per month in person (depending on COVID-19 restrictions). |
| Entry Requirements |
This course is suitable for those with a qualification of a Higher Certificate at QQI Level 6 (120 credits) or higher in Science, Engineering, Quality or a related discipline who wish to develop their knowledge and skills on the application of science in the Pharmaceutical industry. Where appropriate, recognition of prior learning (RPL) and experience may support entry onto this programme. Traditionally we have had significant success in using the RPL option for this programme. |
| Course Content |
Expand+This programme is year one of our 2 year Honours Degree in Pharmaceutical Business Operations. This part-time online course will help you gain expertise in manufacturing, science, regulation quality, technical writing, lean operations and team lead s...
Hide-This programme is year one of our 2 year Honours Degree in Pharmaceutical Business Operations. This part-time online course will help you gain expertise in manufacturing, science, regulation quality, technical writing, lean operations and team lead skills.
The pharmaceutical industry has traditionally required individuals with a strong science or engineering background to support its significant manufacturing activities in Ireland. Today, there is a new skill-set required along with those with scientific knowledge. This skill-set requires professional individuals with a strong knowledge of manufacturing, compliance, regulation as well as business improvement. These skills need to be supported with an ability to assimilate information, make effective decisions and communicate clearly using the latest technologies and systems. Learn more about how industries are changing here.
It is suitable for those who wish to develop their career in the areas of pharmaceutical operations, compliance, business improvement, technology transfer, validation, clinical trials and data analysis. With extensive input and participation from the pharmaceutical and clinical trials sectors, this programme is ideal for those involved in manufacturing, compliance, business improvement, quality assurance, validation, data analytics and clinical trial coordination.
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| Subjects Taught |
Expand+This course is the first year of our Honours Degree in Pharmaceutical Business Operations programme which is delivered over 2 years (ECTS: 180 Credits)
Module 1: Pharmaceutical Manufacturing
Pharmaceutical dosage forms; drug product formulation a...
Hide-This course is the first year of our Honours Degree in Pharmaceutical Business Operations programme which is delivered over 2 years (ECTS: 180 Credits)
Module 1: Pharmaceutical Manufacturing
Pharmaceutical dosage forms; drug product formulation and their chemical function; pharmaceutical manufacturing processes; quality control release testing requirements; stability testing; process validation; change control
Module 2: Management & Organisational Behaviour
Organisational structure and design; organisation culture and change; management & leadership; organisational control and power; workgroups and teams in organisations
Module 3: Operations Management
Operations management; sales & operations planning; planning control and improvement; performance measurement; operational governance
Module 4: Regulatory Affairs & Validation
Regulatory requirements for pharmaceutical manufacturing; distribution and clinical trials; elements of typical cGXP quality systems; clinical trials; pharmaceutical manufacturing; pharmaceutical distribution; marketing authorisation application; current trends in cGMP.
Module 5: Operational Excellence - Lean Sigma
Lean thinking; six sigma; project planning; process mapping; root cause analysis; creative solutions; corrective action preventative action; statistics; data visualisation; presentation skills; effective decision making
Module 6: Control Systems and Real-Time Analytics
Control and data management systems; system development lifecycle; process analytical technologies; real-time control system; critical quality attributes
Module 7: Clinical Research Co-ordination
Research & development process; clinical studies; statistical concepts in a clinical study; drug safety system; regulations & directives applicable to clinical trials; GCP inspection; clinical study reports & clinical overview
Module 8: Career Progression
Fundamentals of developing a successful CV; cover letters; presentation and communications skills; networking; interviewing skills; personal coaching & mentorship
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| Number of Credits |
60 (ECTS) |
| Careers or Further Progression |
Expand+CAREER OPTIONS
Potential career opportunities following the successful completion of this course are highlighted below:
Manufacturing Supervisor / Manager
Supply Chain Planner
Clinical Trials Coordinator
Business Improvement Specialist
Lean...
Hide-CAREER OPTIONS
Potential career opportunities following the successful completion of this course are highlighted below:
Manufacturing Supervisor / Manager
Supply Chain Planner
Clinical Trials Coordinator
Business Improvement Specialist
Lean and Six Sigma
Compliance Specialist
Process Improvement Specialist
Project Co-ordinator
Pharmaceutical Operations
Academic Progression
The options for further study upon successful completion of this course could include progression to the following postgraduate 9 courses:
MSc in Pharmaceutical Business & Technology
PGDip in Medical Device Technology & Business
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| Further Enquiries |
Please note at any time if you have any questions please do not hesitate to contact us by email on admissions@innopharmalabs.com or call us (01) 485 334 |
| Location |
Dublin, Cork. |
| Course Web Page |
Web Page - Click Here |
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