1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

Course Content:

Introduction to GMP Regulation

• The Origin of GMP Regulation

• U.S. GMP Regulation for

  • Drugs

  • Biologics

  • Devices

• International GMP Regulation

  • Commonalities and Differences

  • WHO - USA - Canada - Europe - Japan

• ICH Guidelines

• GMP vs. ISO 9000

GMP Implementation

• Design Controls

• Setting Specifications for

  • Product -Materials and Components

  • Processes - Equipment -Utilities

  • Facility

• Facility and Utility Requirements

• Facility Validation

• Monitoring of Process and Environment

• QC Lab and Test Methods

• Stability Testing Program

• Manufacturing Documentation

  • Policies, SOP’s, MBR, QC Records

• Process Validation

  • DQ, IQ, OQ and PQ of Equipment

• Calibration and Maintenance

• Materials Handling

• Vendor Qualification

• Staff Competence

Documentation

• Structure of an Efficient Documentation System

• Writing of GMP-conforming Documents

• Review and Approval of Documents

GMP Maintenance

• Company Organization

• Document Control

• Failure Investigation

• Corrective Actions

• Change Control

• Self-Inspection

• Inspection by Regulatory Authorities

GMP Audits

• Preparation for Audits

• How to Audit

• How to Behave During Audits

Regulatory GMP-Expectations during the Product Development Process