DURATION
1 Module over 8 Weeks
Study Online 10 hrs/week
APPLY BY
July 15th
Class Starts: July 19th
LEVEL
No Industry Experience Required
Join 1023 Learners
This Course is Right For You If;
- You want to pursue a career in pharmaceutical or medical device industry but don’t have an engineering, science, production, manufacturing or IT background.
- You want to get a basic understand of how pharmaceutical manufacturing works and familiarise yourself with the specialize concepts and terminology involved.
- You are looking for a stepping stone to our follow-on specialization in eValidation or eBioPharmaChem
This course is probably not for you, if
- You already have a background in manufacturing, food production, science or engineering.
What Does the Online Classroom Look Like?
We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.
Hear From People Who’ve Taken This Course
Edel Harkins
“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”
Ronan Balfe
“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”
John Ryan
“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course content material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”
Noel O’Brien
“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”
Anne Reilly
“Very important to do a course if you have been absent from workplace for a relatively long period. It just gives you the confidence to do interviews etc.”
Louise McManus
“Excellent course, well set out.”
Andy Wnuk, MSc (Eng) MIEI
“Along with the technical training in I would rate the course 10 out 10 and would highly recommend to others, very interesting, informative and very well presented. Relevant totally to my needs and expectations.”
David O’Shea, March 2012
“I found this course very beneficial and I am delighted that, even at early stages in the course, it has already provided me with the opportunity to secure a position within the pharmaceutical industry.”
Denis Hegarty, May 2012
“I found the course was run very professionally, The course notes and videos supplied were excellent, the notes tied in very efficiently and accurately with the videos. Dr Joe Brady’s presentation on the videos and his expertise and help at the webinars was outstanding. I found it very easy to continue studying even though I found employment two months into the course. I would highly recommend this course to anyone hoping to further their education in this field.”
Tan Sear Enyu, Venture Corporation Limited, SA
“The lecturers have vast knowledge to share and are technical specialists within the Life Sciences Industry…there was a lot of encouragement and team exchange of experience to bring in for class work and assignment participation.”
Your Lecturer
Dr. Joe Brady
Lecturer, Dublin Institute of Technology
Dr. Joe Brady is an assistant lecturer with the Dublin Institute of Technology (DIT), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer, and highly experienced in competency based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.
He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over seventeen years project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.
Your 8-Week Class Schedule
Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.
And he or she will proactively follow up with you to keep you on track.
Week 1 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 1
- Finished Medicinal Products
- Focus on Patient Safety and Product Quality
- ISO-9001 ‘Quality Management Systems — Requirements’
- Product Quality and cGMP Practices
Week 2 – Industry Regulations & Guidelines for Good Manufacturing Practices (GMP’s) – Part 2
- Regulatory Guidelines for API Manufacturing
- ICH Q10 Continual Improvements
- Quality Systems Regulations – Manufacturing
- FDA Medical Device Rules
- Medical Device Regulations & Guidelines
Week 3 – Process Validation & Documentation
- Process Validation
- ASTM E2500 ‘Specification, Design & Verification of Manufacturing Systems’
- PQ, OQ and IQ (Performance Qualification, Operational Qualification, Installation Qualification)
- Cleaning Validation
Week 4 – Risk Management Tools for making Scientific Based Decisions
- Introduction to Quality Risk Management
- Fault Tree Analysis
- Failure Mode Effects Analysis (FMEA)
- Documenting the Quality Risk Management Process
Week 5 –Key Manufacturing Technologies – Part 1
- Batch Organic Chemical Synthesis
- Biopharmaceutical Manufacturing
Week 6 – Key Manufacturing Technologies – Part 2
- Tablet Manufacturing
- Aseptic & Sterile Manufacturing
Week 7 – Purified Water, Clean Steam & Cleaning
- Purified Water Generation, Storage & Distribution
- Clean Steam
- Water for Injection, Storage and Distribution
- Engineering Aspects of Cleaning
- Chemistry Aspects of Cleaning
- Steam Sterilization
Week 8 – Cleanrooms
- HVAC for Non-Sterile Manufacturing
- Cleanroom Layout
- Area Classification Protection
- Cleanroom Gowning
- Cleanroom Monitoring
Complete the Following Activities & Workshops
Engage in a series of activities during the course including:
- How and where to apply risk management techniques for making decisions
- Writing an Achievements Based CV
- Interviewing Effectively
Certified by GetReskilled
You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Dublin Institute of Technology (Ireland) subject to the following criteria;
- Passing a written or oral Exam on the materials.
- The submission of all assessments and the end of module assignment.
Show Off Your New Skills: Get a Certificate of Completion
Once the course is over, complete a written assignment to get certified in Manufacturing Safe Medicines & Medical Devices Course
Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.
Frequently Asked Questions
- Is this course delivered online? Yes
- Can I pause the class if I get to busy at work or because of family commitments? Yes
- Are all course materials available 24/7? Yes
- Can I take this program at my own pace? Yes
- Do I need to be online all the time? No you don't
- I live in the UK/Europe/USA/Australia etc,. Can I still take this program? Yes
- Can I spread the payments over a couple of months? Yes
- Will I have my own personal course leader who follows up with me to make sure I get to the end of the course. Yes
- Will I have access to the materials after the course is finished? Yes for 6 months.
Price
One Person
Price For 1-Person
$699
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
£599
Price
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
$699
One Person
Price For 1-Person
£599
Price
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
$699
One Person
Price For 1-Person
£599
Price
One Person
Price For 1-Person
£599
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
€599
One Person
Price For 1-Person
$699
Start Your Application
Click below to start your application.
Talk To Our Team
USA/World
Call Geraldine: +1 (617) 901 9268
Ireland
Call Sinead: +353 (0)21 2409016