|
|
|
|
|
|
|
|
|
Pharmaceutical Engineering
11-13 November 2008
Vienna, Austria
Please click here to view the program of this conference or course
To book for this program, just click on the option:
| |  |
At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
| |
Learning Objectives
Persons in positions of responsibility in the engineering and manufacturing departments as well as from plant engineering must deal with the implementation of specifications given in the GMP and FDA regulations. Frequently these persons and those performing the relevant tasks within the company are faced with the question of how the generally valid requirements of these codices can be implemented in actual practice. It will be the task of this GMP Education Course to throw some light on this subject.
Intensive course focussing on the following key tools:
I Regulatory Requirements
The requirements of, for instance, FDA, EC, PIC and WHO form the basis for quality-conform, i.e. GMP-compliant, pharmaceutical manufacture. The question of where concrete requirements can be found is answered during the introduction.
II Technical Documentation
Owing to the large number of official inspections, the GMP-/FDA-compliant documentation in pharmaceutical engineering has become a focus of interest in recent years. The requirements on technical documentation in the pharmaceutical industry will be shown and examples, elaborated in workshops.
III Design Complying with GMP/FDA
In addition to the regulations concerning the manufacture itself and quality control, a GMP-compliant plant design is the initial requirement for fulfilling these guidelines. In this respect GMP-/FDA-compliant plant design is of crucial importance for active ingredient and medicinal product safety.
IV Validation, Qualification
Validation and qualification are attached great importance in pharmaceutical manufacturing. National and international codices as well as official inspectors see in qualified plant and validated processes an important aspect in the creation and maintenance of pharmaceutical quality.
V Maintenance, Change Control, Audit
Regular and preventive maintenance in pharmaceutical production as well as the documentation of changes is to be considered an important part of quality assurance. Much attention is paid to these measures in inspections and audits.
LEARNING OBJECTIVES:
What are the regulatory requirements ?
- Guidance how to interpret the requirements of the international authorities
- Which are the important documents for engineers ?
GMP/FDA compliant design
- Hygienic design principles with many examples from practice
How to achieve the qualified/validated status
- From user requirement to the Validation Master Plan
- Examples for DQ, IQ, OQ and PQ including FAT and SAT
Maintain the qualified/validated status
- Equipment maintenance and calibration
- Change Control, deviations and audits |
|
|
|
|
|
|
