Course offering number:0812-104
Course ID:
2091
ICH-Q7
3-5 December 2008
Amsterdam, The Netherlands
Who Should Attend
This course is for individuals working in all phases of human
and veterinary Active Pharmaceutical Ingredient (API)
production and control including:-
QA/QC
- Auditing
- Validation
- Regulatory Affairs
- Pilot and Commercial Production
- Engineering
- Technical Services
- Process Development
Corporate managers benefit from opportunities the course
offers for individual and group discussion of compliance
issues. Regulatory Agency Investigators are encouraged to
attend.
Description
This course will prepare you to meet the varied challenges
now facing the global active pharmaceutical ingredient
industry. It is important that API production facilities operating
under different national and international regulatory authorities
not be required to meet diverse standards. For this reason an
Expert Working Group in ICH developed the ICH-Q7
document as a single standard that all suppliers must apply to
production of APIs used in human drug products
manufactured in any of the ICH signatory regions.
This course will provide historical insight into the development
of the Q7 document and specific interpretation of
requirements in the document. The Q7 document addresses
all aspects of API production in 19 sections, and each of
these sections will be examined in detail during the course.
Throughout the formal presentations participation by the
registrants is welcome. There are interactive exercises
periodically spaced through the first two days that allow
registrants to analyze real life situations that occur in typical
operations. These afford an opportunity to exchange
information and approaches with colleagues. The final activity
is a workshop in which registrants are asked to apply what
they have learned to resolve issues in test cases.