This conference offers you the unique possibility to become acquainted with the new regulatory requirements of the revised Annex 1, the impact on aseptic manufacturing and the challenges relating to quality aspects.
Authority speakers from different European Member States as well as representatives from pharmaceutical industry will provide you with information on their thinking about the new requirements. They will discuss the statements in the new Annex 1 with regard to topics like Quality Risk Management, Process Simulation/Media Fill and Container Closure Integrity Testing as well as the current expectations on premises, cleanroom qualification and the appropriate monitoring.
Additionally, the speakers will compare the requirements of the new Annex 1 with the expectations of other guidance documents like ISO 14644 or the relevant US guidelines. Every topic will be covered by an authority and an industry representative to compare the regulatory with the manufacturers understanding.
For more details and to download conference brochure visit www.gmp-compliance.org