Approved training courses
Key Learning Objectives
As API supply chains become ever more diverse and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of API sources. This course allows delegates to differentiate between natural variation and risk across a range of API processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.
You will be provided with an overview of the regulatory framework surrounding active pharmaceutical manufacturing process and be given practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration.
You will also learn:
• How to meet 2004/27/EC
• The major differences between chemical synthesis and bioprocesses; and contrasting both against drug product formulation
• How to manage change of API source
• How to audit and provide QA oversight of excipients
• How to audit and how to provide oversight of remote or contract manufacturing capabilities
The course will also allow you to make informed decisions when faced with a range of GMP non-conformances during API synthesis.
Our detailed educational material grows into a lifelong reference library.
Course Content
For chemically synthesized and biologically produced APIs, the course includes:
• Common process steps and their effect on the quality of the final drug substance
• EU and US regulatory requirements
• Comparison and contrast of API facilities
• How GMP is implemented across the key production processes from API starting materials through to packaging and distribution
• Common sources of GMP non-conformance and adulteration or misbranding
• Vendor assurance and management of supply chains including auditing of facilities
Course Outline
Active Pharmaceutical Ingredients
• The regulations
• EU and U.S. regulations and guidelines
• Drug master files and certificates of suitability
• Key GMP guidance – ICH Q7
• Manufacturing processes and quality
• Key issues for:
• Synthesis
• Purification and impurity control
• Packaging
• Process qualification/validation
• Supply issues for the dosage form manufacturer
• Supplier selection and audit
• Supply chain integrity
• Technical/quality agreements
• Certificates of analysis
Bulk Biologicals and Biotech Products
• What is a biological or biotech product?
• EU and US regulatory aspects
• Essential characteristics of biologicals
• Antibiotics
• Vaccines
• Blood products
• Monoclonal antibodies
• Quality aspects
• Control of starting materials
• Control of cultivation, harvest and purification
• Analytical and bioassay techniques
Excipients
• Regulatory environment
• GMP guidance’s/codes
Who Should Attend
The Aspiring Qualified Person
• Our training is generally considered as the best available and our QPs are held in high regard within the industry.
• In addition to being accepted in the UK, our training courses are well known and accepted by several 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 people attending these courses intend to become QPs. Many use the training to develop as technical managers within 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.
For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact QPpharma@nsf.org
Additional infoNSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit nsf.org/training for current dates. If you cannot see your delivery method of choice, please contact QPpharma@nsf.org
Class/lab
5 days
£3780.00 GBP (plus VAT)
Find an approved training course
Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.
Courses are approved for CPD purposes only; approval does not imply they will fulfill any regulatory requirements.
