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Microrite, Inc. EU GMP ANNEX 1 DRAFT CLARIFICATION AND IMPACT- San Juan, PR- March 11th & 12th

Microrite, Inc. EU GMP ANNEX 1 DRAFT CLARIFICATION AND IMPACT- San Juan, PR- March 11th & 12th

Microrite, Inc. EU GMP Annex 1 in San Juan, PR

Date: March 11th & 12th, 2019

Location: San Juan, PR


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:

  • Impact of each important change will be addressed with relevant case studies which will have bearing on your facilities, processes and policies
  • Real world risk assessment with pertinent standards and guidances that can provide information on assessing contamination risks
  • Discussion on how to implement the proposed Contamination Control Strategy

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:

  • Scope
  • Principle
  • Pharmaceutical Quality System
  • Personnel
  • Premises
  • Equipment
  • Utilities
  • Production and Specific Technologies
  • Viable and Non-viable Monitoring
  • Quality Control
Which industries does this workshop apply to?

Pharmaceuticals, Medical Device, Biotechnology

Who will benefit?

QC Microbiologists, Manufacturing, Quality Assurance, Validation, Facilities and Training

Partner


Event Details

About Microrite, Inc.

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.