Location: Cambridge, MA
The Annex 1 revision represents the latest global regulatory thinking in regards to manufacturing medicinal products. This major proposed revision includes input from all PICs member countries including US, Europe and others.
THIS REVISION NOW APPLIES TO STERILE, LOW-BIOBURDEN AND TERMINALLY STERILIZED PRODUCTS
In this two day intensive workshop the following will be addressed:
Microrite’s Contamination Control and Microbiology Experts will perform a comparative analysis of the 2008 Annex 1 to its proposed revision. This will be inclusive of statements and recommendations made by regulatory authorities, 483 observations and warning letters, supplemented by Microrite’s vast experience in assisting companies in prevention and remediation of contamination.
Each of the following sections in the proposed revision of Annex 1 will be discussed with respect to changes which may affect your facility, process, procedures and policies:
Pharmaceuticals, Medical Device, BiotechnologyWho will benefit?
QC Microbiologists, Manufacturing, Quality Assurance, Validation, Facilities and TrainingPartner
Microrite is a San Jose, CA based Consulting and Training Company helping Pharmaceuticals, Biotechnology , Medical Devices and Drug-Device Combination Products, Biofuels and In Vitro Diagnostics in the areas of Quality Assurance, Quality Control, Microbiology, Process Development, Process Validation, Facility and Utility Validation and Equipment Validation.