Formulation and Processing (Part 2 - Sterile Products)
What you'll gain from this course
This is our PART 2 learning option Learn more about PART 1.
The QP must understand formulation and processing principles to make informed certification and release decisions.
This course is delivered in two parts:
Part 1 – Non-sterile products (Virtual, February)
This course helps aspiring QPs and pharma professionals understand key quality requirements for manufacturing capsules, liquids, topical medicines and inhalation products.
Part 2 – Sterile products (In-person, March)
This course explains essential quality requirements for sterile product manufacture, including formulation requirements, critical process steps, quality attributes, process parameters and common issues affecting safety, quality and efficacy.
Once a new chemical entity shows clinical potential, the challenge is turning it into an effective, reliably manufactured medicine. This course covers the formulation and processing activities needed to ensure safety, quality and efficacy, including:
- How the physico-chemical properties of the drug and therapeutic indication influence:
- Route of administration
- Dosage form
- Bioavailability
- Manufacturing methods for major dosage forms
- Factors affecting dosage form suitability
QPs and pharma professionals must understand these topics to:
- Support effective quality systems
- Contribute to risk assessments for process changes and deviations
- Assess cleaning strategies and validation activities
- Evaluate the impact of changes to starting materials
This course is approved by the Royal Society of Chemistry as suitable for members’ continuing professional development.
Our A-Z of Sterile Products Manufacture course can be used instead of Part 2 if you're working towards QP eligibility and the scheduled dates are unsuitable.
Course TutorsEach course tutor has at least 25 years’ hands-on experience in the manufacture of every major dosage form. APIs, biologics, tablets, liquids, creams, ointments, sterile as well as non-sterile dosage forms – you name it, they have made it.
Course tutors will be selected from:
Part 1: Catherine Kay, Samantha Clack, Vicky Baulch, Lecturer from the University of Strathclyde
Part 2: Darren Jones, Phil Rose, Marie O'Callaghan
Discounts
Multiple delegate discounts are available on this course. Please contact us at [email protected] for further information. NHS staff will receive an automatic discount when registering with an NHS email address.
Learning Outcomes
On completion of this course delegates will know and understand:
- The principles of drug design and formulation and the impact of even minor modifications on bioavailability/bioequivalence
- The various processes involved in the manufacture of major dosage forms, e.g. tablets, capsules, oral liquids, topical liquids, creams and ointments, sterile products and inhalation products
- The Good Manufacturing Practice (GMP) issues and challenges for the QP to enable informed release decisions
- How to apply the knowledge to:
- Risk management
- Risk assessment
- Problem solving and decision making
- Auditing
- The principles of technology transfer and process validation
Who Should Attend
The Aspiring Qualified Person
- Our training is generally considered the best available and our QPs are held in high regard in the industry.
- As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries including Ireland, the Netherlands, Austria, Hungary and Malta.
- You are more likely to become a QP with us than with any other training provider.
The Pharmaceutical Technical Professional
- Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
- Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.
Need help choosing?
Our training advisors can help you find the perfect match.