Location

Productivity and Quality Institute - Alexandria

Objectives

• • help you implement into an organization the increasing legislation and guidance on goods within the pharmaceutical industry.

Outcomes

• Participants will be able to describe GMP requirements as they apply to pharmaceutical Laboratories, recognize key concepts related to laboratory documents, learn the requirements for laboratory training and gain a basic understanding of laboratory calibration requirements• Explain the Global Regulatory framework & guidance• Describe the concepts of marketing authorization and regulatory data protection• Discuss the key issues that impact the choice of the registration procedure• Describe the lifecycle management

Course Contents

GMP requirements for laboratoriesLaboratory documents and document controlHandling and documentation of raw dataControlling growth mediaAseptic techniquesMonitoringLaboratory equipment & CalibrationTraining practicesThe Regulatory Agency Governance Global Regulatory framework & regulations 7 guidanceSite master file (SMF)Drug master file (DMS) Marketing Authorization for Medicinal productsLifecycle ManagementChange control & management Audits & self-inspections