This event is cancelled or expired.
Mar
2017
Pharmaceutical Legislation Update
United Kingdom, Manchester
22 Mar 2017 - 22 Mar 2017
Entrance: £770.00 (excl.VAT)
Early bird and multiple delegate discounts available. Discounts also offered to NHS staff, charities and regulators.
Targeted audience:
Quality Assurance personnel, in particular Qualified Persons
Other technical/managerial personnel responsible for the manufacture and testing of APIs and medicinal products
Course overview :
International pharmaceutical laws, regulations and guidance change at a frightening pace –it’s difficult to keep up! That’s why we have developed this 1 day “refresher” course for you. We keep track of all the changes so you don’t have to – just come along and learn what’s new and what’s on the horizon. Ideal CPD for the busy Qualified Person or pharmaceutical quality professional.
About this course :
A detailed review of the ever-changing regulations
Pharmaceutical legislation and regulatory authority guidance is continually changing. These changes to legislation and guidelines, and the interpretation of them, can have significant implications for companies. Many changes require detailed planning to implement and failure to do so can result in serious compliance problems.
This is the continuation of a very successful series of one-day seminars that are designed to form part of your Continuing Professional Development (CPD). This course is also Royal Society of Chemistry approved as suitable for their members’ CPD.
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.
Key Learning Objectives:
To understand and discuss the current interpretation of recently implemented and proposed changes to :
- EU legislation: Directives and Regulations; including the CT, GMP and Safety Features Regulations
- EU GMP: Chapters and Annexes; including ATMP GMP and Annexes 1, 17 and 21
- ICH guidance; including ICH M4E(R2), Q3D, Q12, M9 and M10
- US legislation and FDA guidance
- UK MHRA requirements and processes; including the potential impacts of Brexit on Biopharmaceutical processes in the UK
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Peter Gough
Executive Director
MSc, CSci, CChem, FRSC, FCQI, CQP
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Roger Guest
Consultant in Biotechnology
NSF Health Sciences Pharma Biotech
Resume
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.
Roger Guest is a registered pharmacist who has held senior leadership roles within R&D, manufacturing and QA with several blue chip pharmaceutical and biotechnology companies. He has worked extensively in Europe and the U.S.
His global roles have included leadership of R&D Good Manufacturing Practice (GMP) compliance teams and at a manufacturing facility level, membership of the site leadership teams.
Dr. Guest also has QA experience at department, manufacturing site and corporate levels both within R&D and production.
Dr. Guest’s areas of expertise include :
- Development of IMPs and biologicals from initial formulation through clinical trials and validation to full commercial manufacture
- Transfer of products from R&D to manufacturing
- Design and implementation of new sterile manufacturing facilities
- Active pharmaceutical manufacturing: Complying with cGMP requirements
- Auditing specialization in GMP and due diligence
- Incident management: Troubleshooting and problem solving to root cause Rapid response to global quality issues
- Quality management systems: Development through simplification
- Quality leadership: Promoting that quality makes sense for a better business and helping quality departments integrate their plans with site business plans
- Application of Lean Six Sigma tools to reduce errors and continuously improve processes
- Inspection preparation for FDA, MHRA and other agency inspections (GMP and PAI), including one-to-one preparation clinics
- Group training and one-on-one coaching for quality management understanding and application