This event is cancelled or expired.
Jul
2018
The Role and Professional Duties of the Qualified Person - QP Module
United Kingdom, York
23 Jul 2018 - 26 Jul 2018
Entrance: £0.00 (excl.VAT)
Multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Targeted audience:
The Aspiring Qualified Person
Pharmaceutical Technical Professional
Summary :
The role and duties of the QP are constantly changing and the revision of EU GMP Annex 16 introduces some significant new expectations. It is, therefore, essential that QPs keep up to date. This course covers these new challenges in details to help you understand them and their impact.
Of paramount importance is the ability to focus on the broad issues of managing quality and to bring these issues together in a cohesive way when making decisions to certify medicinal products, so throughout the course you will have the oppotunity to test your skills via interactive "release or reject" scenarios.
The course will also include a simulation of a typical UK QP assessment interview as conducted by the three professional bodies. This course is also RSC Approved.
Benefits :
- Provides aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the QP’s legal duties
- Demonstrates how the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society
- Will help you to understand what the QP must do themselves and what can/must be delegated to others, how the QP should work in tandem with professionals in other departments, and will stress the non-technical people skills that are essential to being a good QP
Course overview :
This intensive, interactive 4 day training course is designed to provide aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the legal duties of the QP and, more importantly, how the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society. This course will help you to understand what the QP must do themselves and what can/must be delegated to others, it will provide advice on how the QP should work in tandem with professionals in other departments, and will stress the non-technical “people” skills that are essential to being a good QP.
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.
Detailed QP legal and professional duties
- Including a detailed review of the revised Annex 16
QP Code of Practice
- Implications for the QP
Current challenges facing the QP
- Proposed and recently implemented legislation and guidance
Product certification/release criteria
- The decision making process
- To certify or not to certify?
Future of the QP role
EU legislation and its implications
Role of the QP in complex manufacturing scenarios
- Annex 16 and beyond!
How to be an effective QP
- Influencing skills and assertiveness
- Leadership
- Conflict management and coaching
Routes to becoming a QP across the EU and the UK assessment procedure
- Education and training of QPs
- Simulation of a typical UK QP assessment interview procedure
Links with other stakeholders
- The regulatory authorities and the inspectors
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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
-
Peter Gough
Executive Director
40 years’ experience of pharmaceutical manufacture
Resume
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.
A chemist with a master’s degree in analytical chemistry, Peter Gough has nearly 40 years’ experience of pharmaceutical manufacture, control and quality management, culminating in the role of Senior Quality Consultant in Eli Lilly’s Global Quality Systems division. He has broad experience, particularly with quality control laboratories and the manufacture of solid dosage forms and active pharmaceutical ingredients. He was previously a partner at David Begg Associates (DBA).
Mr. Gough has extensive experience defining quality systems at a global level. He is eligible to act as a Qualified Person and is an Honorary Lecturer in GMP and Pharmaceutical Quality Management at the University of Strathclyde. He is a former member of the European Federation of Pharmaceutical Industry Association’s (EFPIA) Manufacturing and GMP ad hoc group and was EFPIA topic leader on the ICH Expert Working Group which prepared the Q9 Quality Risk Management Guideline. He was given the Leveraging Collaboration Award by the U.S. FDA for his contribution to the online ICH Q9 briefing pack. He has been a passionate advocate of the Quality by Design (QbD) approach to the development, registration and manufacture of pharmaceuticals.
Mr. Gough has been a strong proponent of the use of statistical data analysis techniques to drive continual improvement within pharmaceutical quality management systems.
Areas of recognized expertise include:
- Pharmaceutical law
- The role and duties of the Qualified Person
- Pharmaceutical quality management systems
- Pharmaceutical quality risk management
- Good Control Laboratory Practice (GCLP)
- Managing out of specification (OOS) and out of trend (OOT) results
- The application of statistical process control tools
- The manufacture and control of oral solid dose products
Mr. Gough is a Fellow of the Royal Society of Chemistry and of the UK Chartered Quality Institute (CQI) and former chairman of the Royal Society of Chemistry’s Qualified Person Assessor Panel and of the CQI’s Pharmaceutical Quality Group.