About this course
Quality Control (QC) laboratories perform a vital role within Good Manufacturing Practice. They provide the data upon which critical decisions, such as batch release and the stability of products, are based. If the laboratory data is incorrect then decisions may be wrong with potentially disastrous consequences for companies and patients.
So ensuring the integrity of the data produced by QC laboratories is essential and a key component in providing data integrity is the validation of the test methods.
This course aims to give you an overview of current best practices for the development, documentation, validation and transfer of analytical methods for use in QC laboratories performing chemical testing on active pharmaceutical ingredients (APIs), investigational or marketed pharmaceutical products.
This course is designed to provide you with practical advice and detailed guidance on analytical method validation, based on the ICH Q2 guideline and on pharmacopoeial method verification, based on USP general chapter 1226.
Many organisations encounter difficulties when they attempt to transfer methods from one laboratory to another. This course will provide you with strategies and approaches to ensure success in this complex area.
What You Will Learn
- What makes a good chemical analytical method
- Effective documentation of analytical methods
- ICH Q2 requirements for analytical method validation
- Validation approaches during early phase development
- Pharmacopoeial method verification
- How to plan and execute a successful method transfer
Course outline
Analytical Methods
- What makes a good method
- How to document an analytical method effectively
Analytical Method Validation
- ICH Q2 requirements
- What to do during development phases
Verification of Pharmacopoeial Methods
Analytical Method Transfer
- Planning and preparation
- Defining acceptance criteria
- Equivalence testing
The course will begin at 09.00 and finish at 16.00
Best Practice for the Analytical Laboratory
The integrity of analytical laboratory data relies on the knowledge, understanding and training of all the people involved
Over the past 25 years NSF-DBA has built a strong reputation for providing high quality training on numerous aspects of Good Manufacturing Practice. We are pleased to be able to offer you a suite of three linked courses covering current best quality practices for chemical analytical laboratories.
- Analytical Methods: Documentation, Validation and Transfer
- Investigating Out of Specification Results
- Ongoing Stability Testing
This suite of courses is designed to cover a range of inter-related topics covering best quality practices within chemical analytical laboratories.
These courses are designed to provide you with our ‘trademark’ practical advice on what to do to achieve cost-effective quality assurance whilst satisfying current regulatory authority expectations.
Those of you who are new or less experienced will benefit from the whole suite. We will provide you with the knowledge and practical interpretation you need to perform your duties.
Those of you with greater experience or who are changing roles may wish to focus your participation so we enable you to select which modules to attend.
Each of the related courses will explore the detailed aspects of the topics that cause you concern and we are available at all times to answer your specific questions. Attendance will enable you to network with other delegates and benchmark your laboratory’s performance.
Venue
Manchester Marriott Victoria & Albert Hotel, Manchester, UK
The Manchester Marriott Victoria & Albert Hotel stands on the banks
of the River Irwell, near the city centre but convenient for Manchester
Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.
Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and the Living Well Health Club with pool, gymnasium, sauna and steam room is just a few
minutes from the hotel.
Also nearby are the Imperial War Museum North West, Lowry Museum and Manchester’s three theatres. A few minutes’ walk takes you to the city’s main shopping and eating district.
Hotel Accommodation
- We have a block booking of bedrooms at the Manchester
Marriott Victoria & Albert, 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:
Chris Burgess
Dr Burgess also has 35 years’ experience in the pharmaceutical industry primarily with Glaxo in Quality Control, Quality Assurance and Analytical R&D. Dr Burgess has published over 70 papers and books in analytical science. He is a member the PDA (USA) Scientific Advisory Board on OOS Task Force and presented at the PDA/FDA meeting of the new OOS Guidance in December 2006 in Washington DC.
What you've said
“This is complex material, however, the tutors explained the contents in an understandable way. Most importantly they point the direction for looking for information and references.”
Qian Cai, Apatech, UK
“Course material is very helpful and the tutors were great! Especially teamwork will help.”
Madhavi Kunkalienkar, Goldshield Pharmaceuticals, UK
“I had limited knowledge about validation but now I have got a considerable idea about validation.”
Roopa Bhat, Goldshield Pharmaceuticals, UK
“Experience and knowledge of the tutors is obvious and beneficial.”
Martin Burrows, Warner Chilcott, UK
“Excellent overview of validation requirements and regulatory issues.”
Ken Fergusson, Smith & Nephew, UK
“Excellent course! Would recommend it to anyone working in QA and QC.”
Anne Mette Nygard, Xellia Pharmaceuticals, Norway
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