Who Should Attend

This two-and-a-half day course is designed for pharmaceutical R&D or manufacturing personnel who are in any way involved in the development, manufacture, testing, release and/or registration of solid oral dosage forms of small molecule pharmaceuticals.

Typical attendees include (but are not limited to) professionals in:

• Formulation Development
• Process Development
• Clinical Supply Manufacturing
• Commercial Manufacturing
• Analytical Development
• Quality Control
• Quality Assurance
• Validation groups

The course will also benefit those in other departments (e.g. Regulatory Affairs, Project Management) who are responsible for supporting the development and/or registration of solid oral dosage forms.

Learning Objectives

Upon completion of this course, attendees will have a clear understanding of the technical/ scientific principles and regulatory requirements to be taken into consideration for preformulation, formulation and process development, manufacturing, and testing of solid oral dosage forms (tablets and capsules). Attendees will have gained the background knowledge necessary to effectively design and execute a development plan for tablets and capsules, including drug product registration. In addition to conventional tablets and capsules, participants will also acquire insight into development of specialized dosage forms, for example: poorly water-soluble drugs and modified release drug products. In addition to scientific and regulatory know-how, attendees will gain practical knowledge through case studies which can be directly applied to projects. 

Course Description

This course provides comprehensive and up-to-date knowledge of development, manufacture, testing, release and/or registration of solid oral dosage forms of small molecule pharmaceuticals. The course covers formulation design considerations for tablets and capsules and unit operations utilized in the manufacture of the solid oral dosage forms. In addition, this course will cover the regulatory requirements for drug product registration (International Conference on Harmonization guidelines), including testing requirements, stability studies, and format/content of regulatory dossier for worldwide registration/approval (CTD format). This course will prepare attendees to design and execute effective formulation and process development plans for solid oral dosage forms. In addition, the course will address specific considerations in the development of challenging molecules, such as poorly water soluble drugs. The course will also cover development of specialized dosage forms such as modified release products and fast dissolve tablets.

Additional benefits of this class include:

• A Reference List of scientific publications and regulatory guidance documents
• Learn not just from the course director, but tap into the knowledge of your peers: Participants will have the opportunity to bring their development and/or manufacturing challenges, problems, and issues for classroom discussion
• Participants will also have the opportunity for direct one-on-one interaction with the course director during course breaks and in the evenings. The course director has over 18 years of pharmaceutical industry experience in the development and registration of various solid oral dosage forms for new molecular entities

View Course Agenda