• Regulatory Guidelines for API Manufacturing
• ICH Q10 Continual Improvements
• Quality Systems Regulations – Manufacturing
• FDA Medical Device Rules
• Medical Device Regulations & Guidelines

• Process Validation
• ASTM E2500 ‘Specification, Design & Verification of Manufacturing Systems’
• PQ, OQ and IQ (Performance Qualification, Operational Qualification, Installation Qualification)
• Cleaning Validation

• Introduction to Quality Risk Management (QRM)
• Fault Tree Analysis (FTA) – ‘Workshop’ exercise
• Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – ‘Workshop’ exercise
• Documenting the Quality Risk Management Process

• Batch Organic Chemical Synthesis
• Biopharmaceutical Manufacturing

• Tablet Manufacturing
• Aseptic & Sterile Manufacturing

• Purified Water Generation, Storage & Distribution
• Clean Steam
• Water for Injection, Storage and Distribution
• Engineering Aspects of Cleaning
• Chemistry Aspects of Cleaning
• Steam Sterilization

• HVAC for Non-Sterile Manufacturing
• Cleanroom Layout
• Area Classification Protection
• Cleanroom Gowning
• Cleanroom Monitoring

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

• The key requirements of a quality management system
• The manufacturing responsibilities for quality systems
• The cleaning validation sequence and how to determine cleanliness levels
• The documentation of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.
• The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
• The critical process parameters and quality attributes associated with the manufacture of tablets.
• The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
• The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

Now you will start the Advanced Career Coaching elements of this course to develop the skills you will need to find a job in this industry.

• Learn about your local BioPharma/MedTech manufacturing industry in detail
• Understanding pharma industry jargon.
• How to find the roles that are right for you

• How to job hunt when you already have a job
• Assessing your own skill set and how to sell that to employers
• What employers expect from your application
• CV and cover letter writing skills that are highly tailored to a job advert with personalized feedback

• Develop a list of appropriate companies and people for speculative job applications
• Practice writing speculative applications
• How to make successful speculative applications

• Network effectively both on and offline
• How to use social media in your job hunt
• Interview preparation
• How to deal with psychometric testing

Complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques you have learned, including the following;

• Discuss your local BioPharma/MedTech manufacturing industry
• List the departments and job roles where your skills are best suited
• Understand your current skill set and how to discuss that with employers
• Network effectively both on and offline
• Write a CV and a cover letter that are highly tailored to a job advert
• Write a speculative application and have a list of local companies appropriate for such an application
• Prepare for an interview

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.