About this course
About NSF-DBA
NSF-DBA has been providing learning and development solutions to the pharmaceutical industry in Europe for the last 25 years and we always like to respond to the market requests for new topics or training in new territories. NSF-DBA is delighted to bring to Istanbul our very popular and highly successful Good Manufacturing Practice training course. In recent years over 1000 delegates from Europe, North America and Asia Pacific have attended this course with levels of experience in the pharmaceutical industry ranging from days to decades. Feedback is extremely positive, with this course being one of our highest scoring among delegates.
We recognise that Turkey has a growing pharmaceutical industry and we would like to support the education and training of the key personnel in this market place, to ensure the quality of products produced and distributed both in Turkey and to the rest of the world.
We start this process with our most successful course ‘Pharmaceutical GMP’ and hope that you enjoy the course and NSF-DBA’s unique style of presentation and learning. NSF-DBA is fortunate to work with a range of industry experts and they bring their vast experience to our courses to share with you. We hope this will be the first in a series of courses for this region.
About This Course
It is a legal requirement that all staff receive regular training in Good Manufacturing Practice.
The course is designed to explain the rules and guidance for GMP as required by Directive 2003/94 and leads the delegate through a practical interpretation of EudraLex Volume 4 Part I Chapters 1-9, elements of Part III and some key annexes. This is highly relevant for any company planning to sell product into an EU country or into any other PIC/S market.
Europe’s Most Popular GMP Course!
- In the last 8 years, over 1000 delegates from all over Europe have attended this course
- This course repeatedly achieves the highest customer satisfaction level, with 95% of delegates rating it “very good” or “excellent”
- This course now forms an entry level GMP training for our very popular ‘Effective Pharmaceutical Audits and Self-Inspections’ course recently certified by IRCA (International Register of Certificated Auditors). A great opportunity to begin the process of gaining a unique qualification to be a Pharmaceutical Quality Management System Lead Auditor
While the course is mainly targeted at people in their first 3-5 years in the industry, it is also regularly attended by more experienced individuals, who want to benchmark knowledge against current requirements or who have changed roles and find themselves in a GMP environment. It is also suitable for Supervisors and Managers, for QA, QC, Production and Engineering plus a range of support roles.
Course outline
Why we have GMP
EudraLex Volume 4
- Structure
- Content
- Application
A clear comparison of EU and FDA GMP requirements
- Areas of agreement
- Critical differences
Up-to-the-minute information on new GMP initiatives and regulations
- FDA’s cGMP for the twenty-first century
- Changes to EU GMP regulations…
- Product Quality Review
- Ongoing Stability Testing – reference samples and retention samples
- ICH Q9: Quality Risk Management
Practical advice on dealing with the ‘difficult areas’ of GMP
- Change Control
- Deviations
- Assessing the effectiveness of training
An understanding of how GMP is influenced by…
- Premises
- Processes
- Products
- Procedures
- People
An appreciation of the critical GMP issues for…
- Solid dosage forms
- Sterile products
- Liquids/semi-solids
- Packing operations
- Computers
A panel discussion session to explore YOUR specific GMP problems
Venue
Reinassance Polat Istanbul Hotel, Turkey
Ideally located, with easy access to Istanbul International Airport, CNR-Expo, IDTM and all major Istanbul motorways, the Renaissance Polat Istanbul hotel provides you with first class service & accommodations.
As well as free shuttle service to and from the Airport and Istanbul city center, the Renaissance Istanbul hotel features spacious air-conditioned accommodation, safe and LCD screen TV’s.
Hotel Accommodation
- We have a block booking of bedrooms at the Hilton York Hotel, at
a specially negotiated bed and breakfast rate per delegate per night.
- As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
Delegates on a previous GMP course said:
“Complete overview on GMP – that was what I was looking for. Regained my motivation to continue working in QA.”
Markus Schoester, Novartis Pharma, Switzerland
“An excellent course delivered in a memorable way. I shall certainly be recommending NSF-DBA to others in the industry and shall be attending other DBA courses in the future.”
Gina Collier, Reckitt Benckiser Healthcare, UK
“Coming from a GMP background I found the course a very good introduction to GMP. I found the tutors very engaging and made the whole course fun to be part of.”
David Conlon, Celerion, UK
“Excellent course to get a complete overview of all GMP aspects! Special compliments to tutors for how they keep our attention during those days! Good balance of theory and day to day examples.”
Janet Wonink, Organon, The Netherlands
“Superb, enjoyable and expertly delivered.”
Doug Strachan, Emcor, UK
“The standard of lecturers/presenters was excellent, very impressed with the quality and completeness of the material covered.”
Gerrard Kemmy, Covidien, Republic of Ireland
“It is a fun and relaxed way of knowing much more about GMP.”
Elma Snijder, Solvay, The Netherlands
“Very good course, obviously amount of content is reliant on amount of time available. Tutors allowed enough time for questions and were very approachable. They had extensive knowledge. This course is very suitable for everyone who has an active role within a GMP environment, even suppliers to the GMP companies.”
Kelly Lindsay-Jermey, Sanofi-Aventis Pharma, UK
“Really great tutors answering all our questions. Absolutely nice mix of lectures and buzz group working. The course had great content (for starters) and was very well presented.”
Hans-Juergen Franke, B Braun Medical, Switzerland
An NSF International Company
