Pharma cGMP Utility Systems Management

Date	Aug 16, 2018
Time	11:00 PM EDT
Cost	$87230.00
Online

Every Pharmaceutical personnel must be knowledgeable about pharma grade water systems, utilities and requirements to assure their employees produce safe products for patients. If the Water doesn’t meet Required Standards, Pharma products cannot be manufactured and sold. Quality Units must Sample and Test the Water to assure the Water systems are operating at Regulatory required levels. Training of personnel to assure the water produced meets and maintains regulatory standards is critical to a company’s success.

Learning Objectives:

• Review of Effective Installation/Operation Process Systems
• FDA and USP vocabulary and Terminology
• Lifecycle Approach to Maintaining a State of Validation
• FDA Inspection Readiness – Are You Prepared? Do you Know what is expected?
• Emerging Regulations and Enforcement Trends in cGMP Utilities and Prevention of Problems That could shut down the systems
• Validation Considerations for Multi-Products Transfer to Manufacturing Facilities
• User Requirements and Implementation of a Risk-Based, Compliant Management System.

Who Should Attend:

• Quality Assurance Personnel and Management
• Quality Control Personnel and Management
• Regulatory and Compliance Personnel and Management
• Process Engineering Personnel and Management
• Utility Engineering Personnel and Management
• Facility Engineering Personnel and Management
• Manufacturing Personnel and Management
• Validation Personnel for Water System Qualification
• Laboratory Managers
• Testing Analysts and Technicians
• Microbiologist Personnel and Management