Courses and Conferences on GMP Compliance in the Pharmaceutical Industry
The implementation of the Good Manufacturing Practice (GMP) principles is often referred to as GMP Compliance. The quality assurance system and the documentation are the fundamental basis of each GMP system. EU GMP Guide Part I Chapter I states: „The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the relevant Marketing Authorisation(s) and do not place patients at risk due to inadequate safety, quality or efficacy.” It further states: „An effective quality management system is essential to the realization of this quality objective reliably, the manufacturer should establish, document, and implement a comprehensively designed and correctly implemented Quality Management System incorporating Good Manufacturing Practice, Quality Assurance, Quality Control and Quality Risk Management principles.”
Quality assurance must be a comprehensive and company-wide system which has to be extensively documented. In the pharmaceutical environment, ISO 9001 has no importance. Nevertheless, a few elements taken from the ISO 9001 standard have flowed into one international harmonized Guideline; namely the ICH Q10 on Pharmaceutical Quality Systems. Together with ICH Q9 on Quality Risk Management, ICH Q10 is the core of modern pharmaceutical quality assurance. This includes also appropriately qualified and trained personnel.
We regularly organises conferences and courses on GMP Compliance:
- Change Control
- Complaint Handling and Pharmacovigilance
- Deviation Management and CAPA
- Efficient Batch Record Review
- GMP and FDA compliant Quality and Documentation Systems
- GMPs in Storage, Transportation and Cold Chain
- ICH Q9 Training Course
- ICH Q10 Training Course
- Integrated and Efficient Supplier Qualification
- Pharmaceutical Contracts: GMP and Legal Compliance
- Product Quality Review
- SOPs Design, Management and Training
You may also join the GMP certification programme Certified Quality Assurance Manager
