Analytical Methods: Documentation, Validation & Transfer

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 two-day pharmaceutical training course provides a detailed explanation of how analytical methods are validated, enabling a full understanding of method performance characteristics and associated statistics, and how they are applied to the techniques used for analysing drug related samples. This knowledge will enable informed interpretation of the regulatory guidance on validation, namely ICH Q2(R1) and guidance from FDA and EMA on bioanalytical methods.

Many organisations encounter difficulties when they attempt to transfer methods from one laboratory to another. This pharmaceutical training course will provide you with strategies and approaches to ensure success in this complex area.

What You Will Learn

After attending this course you will be able to:

• Understand the purpose of analytical method validation
• Define the parameters used for method validation, ie validation characteristics
• Generate a validation protocol including relevant acceptance criteria
• Interpret the results of validation using appropriate statistics
• Understand best practice for analytical method transfer

Course outline

• Introduction to analytical method validation
• Uncertainty in analytical measurement
• Statistics for analytical method validation
• Validation characteristics, as defined in ICH Q2(R1)
• Validation protocols
• Analytical method transfer
• Validation reports

Venue

Manchester Marriott Victoria and 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 a few minutes’ walk takes you to the city’s main shopping and eating district.

Hotel Accommodation

• Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
• To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
• This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
• 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.

Venue Address and Contact Details

Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England

Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484

www.marriott.co.uk

Hotel Bookings

If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following “this link”- link to be confirmed

This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.

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 expert for this course is:

• 

  Mrs Oona McPolin
  Consultant
  BSc, MSc, CSci, CChem, MRSC

  • [email protected]
  • +44(0)1751 432999

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

“I benefitted a lot from the method validation, method transfer as it gave me new ideas which will help me with my work.”

Sanaa Ali El-Sammani, Saudi FDA, Saudi Arabia

“Course content would probably be suited to two days to allow in depth training.”

David Bentley, Alba Bioscience, UK

“I had limited knowledge about validation but now I have got a considerable idea about validation.”

Roopa Bhat, Mercury Pharma Management Services, 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

Note: these refer to our previous 1 day course