Title of Training	Dossier Reference (CTD, part 2.3.S)
Setting of specifications for In-Process Materials	2.3, 2.4
Organic Impurities and Residual Solvents	3.2.1, 3.2.2
Metal Residues	3.2.3
Genotoxic Impurities	3.2.5
Setting of specifications for Active Ingredient	4.1, 4.2, 4.5
Impurities and Reference Substances	5
Stability Studies for Active Ingredient	7
Fast chromatography: implementation and regulatory impact
Pharmacopoeias: general information and use in practice
"Quality by Design" for analytical methods
Characterization and tracking of impurities along process

Training

Alain Duguet has a long experience in several areas, analytical and regulatory aspects essentially related to Active Ingredient and its manufacturing processes. He has shared this experience in various ways in the past:

Internal training programmes, in companies he worked for

Presentations in international congresses or seminars (see list and examples)

Animation of Working Groups, internal to the company or interprofessional (see list and examples)

He can propose you some training or information sessions on the topics summarized beside. These sessions would be realized on your site. Their content and duration would be customized to your own needs.

Some of these modules may be assembled to design a more comprehensive training session. Most of these trainings include a practical part, where participants are asked to work with the trainer through practical examples and case studies.

For more information, see page Contact