EMA issues guidance document in preparation for Brexit

European Medicines Agency (EMA) is essential to the functioning of the single market for medicines in the EU. The Agency’s work is vital to providing EU citizens with effective, safe and high-quality medicines and to maintain a regulatory environment that fosters innovation and the development of new medicines.

The Agency is working closely with the EU institutions and national competent authorities in the European medicines regulatory network and will continue to share information on the latest developments with its stakeholders.

To Keep up to date

Pharmaceutical Dissolution Testing – a 2 day course, 22 & 23 May 2017, London UK

The effectiveness of pharmaceutical dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the systemic circulation. The rate of dissolution of the product is therefore crucial.

To achieve reliable and reproducible results, it is important that analysts understand the importance of correctly setting up and sampling from  the chosen apparatus.

Who should attend?

This 2 day course is designed for professionals new to dissolution testing and those with previous experience seeking to improve their skills and knowledge, working in the following areas

  • Analytical Development
  • Project Management
  • Quality Control
  • Quality Assurance
  • Regulatory Affairs
  • Pharmaceutical Development

For further information and online registration visit our website

 

 

 

Stability Testing in Pharmaceutical Development and Manufacture, 18 & 19 May 2017, London

BOOK NOW

– an update for the 21st Century

The course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly and complex testing area. Previous participants say that as a result of the course they have been able to significantly reduce testing in some areas, and identified deficiencies in other areas. It will include opportunities for review of specific participant problems

The course will cover:

Recent regulatory changes affecting stability including

  • The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
  • Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
  • Product Quality Reviews and the interpretation of stability data.

Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems

  • ASAP – using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence – Freethink Technologies’ ASAPprime
  • Low level impurities and their impact on product stability
  • Manipulation of tablet internal pH to improve product stability

This course repeatedly receives “Excellent” reviews by attendees.

For further details and to register visit our website

PharmaTraining Courses 2017

Are you ready for 2017?

Do you require a refresher or new skills?

Hands-on Tablet Development including the principles of pre-formulation, formulation and process development 22, 23 & 24 March, Croydon Greater Londononly 4 places remaining

Stability Testing in Pharmaceutical Development and Manufacturing – 18 & 19 May, London

Pharmaceutical Dissolution Testing – a 2 day course, 22 & 23 May, London

Hands-on Tablet Development including the principles of pre-formulation, formulation and process development – 14, 15 & 16 June, Croydon Greater London

Development of Stability-Indicating HPLC Methods – 21 June, London

HPLC Analytical Method Development and Validation – 22 & 23 June, London

Pharmaceutical Packaging – an introductory course – 26 June, London

OOS Investigations in a GMP Environment 17 & 18 October 2016, London

What is an OOS result?

A result that falls outside established acceptance criteria which have been established in official compendia and /or company documentation.

Approved documents such as:

  • Certificates of analysis (C of A’s)
  • Specifications
  • Drug Master Files (DMFs)
  • Official compendia
  • Filed applications, approved marketing submissions
  • Stability protocol

This course is based on the FDA guideline ‘Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production’, October 2006

 

QbD and Lifecycle Management for Analytical Methods

The validation of analytical procedures is an important  part of any process for ensuring drug quality. Since 2014, USP’s Validation and Verification Expert Panel has been considering how the modern concept of lifecycle model process validation can be applied to analytical procedures.

QbD and Lifecycle Management for Analytical Methods 13 & 14 October 2016 London – Book your place now.

The expert speaker for this course is Dr Pauline McGregor.

Pauline is a member of the Validation & Verification Expert Panel at USP.  Pauline McGregor has a pharmaceutical consultant for many years. She has over twenty five years’ experience in the Pharmaceutical industry and holds a Ph.D in chemistry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Pauline has been involved with and has had a passionate interest in the evolution of method development, validation, transfer and verification of analytical methods and has been actively involved in authoring a paper and presenting short talks and training courses on the application of QbD to analytical methods. Pauline is currently a member of the Royal Society of Chemistry, UK and is listed on the RSC Directory of Consultants.