This event is cancelled or expired.
May
2018
Practical Module (Formulation, Manufacturing, Analysis & Biologics) - QP
United Kingdom, Glasgow
14 May 2018 - 18 May 2018
Entrance: £3,575.00 (excl.VAT)
Lunch:
included
Multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Targeted audience:
Aspiring Qualified Person
Pharmaceutical Technical Professional
Course Overview :
In an ever-changing pharma world it is a challenge for QPs and prospective QPs to gain a functional understanding of the equipment and processes used to manufacture and test today’s dosage forms. This course provides hands-on experience to trainee QPs wishing to gain better understanding of what really happens in manufacturing and testing. Share knowledge with industrial and academic experts, solve real life QP problems.
This course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.
Benefits :
- Totally practical, hands-on lab based training at one of the top schools of pharmacy in the UK
- MSc level training with a real industrial perspective
- Understanding the “why” behind the pharma industry processes
- Getting closer to products than is possible in a GMP environment
- Find out what’s really important for your starting materials; use this knowledge to help with your risk based supplier management programs
We don’t just train to pass a Viva – we take the time to prepare you to excel. Our detailed educational documentation grows to a lifelong reference library.
Discussion and working group :
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice. Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific question and concerns.
Registration link :
- NSF Online registration : Link
NSF contact :
- Phone : +44 (0) 1751 432 999
- email : pharmacourses@nsf.org
- visit : www.nsf.org/info/pharma-training
Note :
- All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
This is a totally practical, ‘hands-on’ course covering…
Sterile Products
- Manufacture a terminally sterilized injection
- In process controls and environmental monitoring
- Inspection, analytical testing and sterility testing
- Find out what’s really critical
Tablets
- Wet and direct compression technique
- In process controls
- What goes wrong and the challenges faced by the QP
- Critical control points
Bioprocessing
- Introduction to bioprocess techniques
- Equipment, medium designs and strain selection
- Methods of operation
- Monitoring and control
- Downstream processing
Analysis
- A range of analytical techniques to test raw and finished products
- QP information to make decisions
- Understand your analyst
-
Oona McPolin
Training consultant
pharmaceutical analysis with over 20 years’ experience working in cGMP pharmaceutical laboratories
-
Mike Halliday
Honorary lecturer at the University of Strathclyde
hands-on tablet compression manager and manufacturing manager
-
Erika Notman
Microbiologist
25 years’ experience in the production and control of pharmaceuticals
Resume
Oona McPolin is a training consultant specializing in learning and development relating to chemical analysis, and in particular analysis of pharmaceuticals. She is an expert in a range of analytical chemistry topics including developing methods for and troubleshooting high performance liquid chromatography (HPLC). She has been using HPLC for over 20 years and is particularly interested in strategies for method development including the use of automation, computer simulation and column classification data.
Before setting up her consultancy seven years ago, Ms. McPolin worked as an analytical chemist in the pharmaceutical industry for over 10 years. In this role, she was responsible for developing and validating analytical methods on a range of drug development projects. She was also responsible for many pharmaceutical analysis training programs.
She is the author of two books, Validation of Analytical Methods for Pharmaceutical Analysis and An Introduction to HPLC for Pharmaceutical Analysis.
Mike Halliday has extensive pharmaceutical manufacturing management and QA experience, gained over 20 years working for three major international pharmaceutical manufacturers. Before joining NSF in 2003, he was Associate Director, Global Audit and Compliance for Wyeth Europa. He was also previously a partner at David Begg Associates (DBA).
Mr. Halliday is eligible to act as a Qualified Person and is an honorary lecturer at the University of Strathclyde.
He has broad experience in the manufacturing management and QA of a wide range of sterile and non-sterile dosage forms and is fully conversant with current EU and FDA GMP regulations and requirements. He has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers and specialist distributors in Europe, the Middle East, America and Asia Pacific.
Areas of recognized expertise include:
- QP training
- Packaging and labeling control
- GMP legislation
- API manufacture and control
- Auditing and self-inspection skills – Education of auditors
- Supply chain distribution
A microbiologist by training, Erika Notman has over 20 years of experience in the pharmaceutical industry, in increasingly senior roles in both quality control and quality assurance. She is eligible to act as a QP and is an honorary lecturer at the University of Strathclyde. She specializes in providing auditing, consultancy and training to manufacturers of sterile and non-sterile products, both pharmaceutical and biological.
Ms. Notman has worked with all the major pharmaceutical dosage forms, both sterile and non-sterile, and with medical devices. In addition, she has expertise in controls and systems in the cosmetics and toiletry industries, and is a past chair of the CTPA (Cosmetic, Toiletry & Perfumery Association) Microbiology Sub-Committee.
Ms. Notman previously served as a QP assessor for the Institute of Biology and is a past chair of the Institute’s Panel of QP Assessors.