Spreadsheet: 029bd04b-4d9a-4ba5-8313-91cfc0afec91
Sheet: Curriculum

 | We recommend individuals complete the pre-requisite courses before proceeding to the US FDA GMP Inspection Approach online courses.
 | To maximize and customize your professional development, we have two options available:
 | Option 1: Select each of the six US FDA GMP Inspection Approach online courses for an overview of all the Systems.
 | Option 2: Select a Track and complete the pre-requisites, the US FDA GMP Inspection Approach online course, and the electives.
 | Track A | Track B | Track C | Track D | Track E | Track F
 | Quality Systems | Facilities and Equipment Systems | Materials Systems | Production Systems | Packaging and Labeling Systems | Laboratory Control Systems
SUGGESTED ON-LINE COURSE PREREQUISITES
 |  | USFDA GMP Inspection Approach for Quality Systems | USFDA GMP Inspection Approach for Quality Systems | USFDA GMP Inspection Approach for Quality Systems | USFDA GMP Inspection Approach for Quality Systems | USFDA GMP Inspection Approach for Quality Systems
 | Regulatory Compliance: Government Regulations | Government Regulations | Government Regulations | Government Regulations | Government Regulations | Government Regulations
 | Industry Overview: Drug Dosage Forms | Industry Overview: Drug Dosage Forms | Industry Overview: Drug Dosage Forms | Industry Overview: Drug Dosage Forms | Industry Overview: Drug Dosage Forms | Industry Overview: Drug Dosage Forms
 | Regulatory Compliance: Standards Practices and [NAME] | Regulatory Compliance: Standards Practices and [NAME] | Regulatory Compliance: Standards Practices and [NAME] | Regulatory Compliance: Standards Practices and [NAME] | Regulatory Compliance: Standards Practices and [NAME] | Regulatory Compliance: Standards Practices and [NAME]
USFDA GMP INSPECTION APPROACH ON-LINE COURSES
 | USFDA GMP Inspection Approach for Quality Systems | USFDA GMP Inspection Approach for Facilities and Equipment Systems | USFDA GMP Inspection Approach for Materials Systems | USFDA GMP Inspection Approach for Production Systems | USFDA GMP Inspection Approach for Packaging and Labeling Systems | USFDA GMP Inspection Approach for Laboratory Control Systems
SUGGESTED ON-LINE COURSE ELECTIVES
 | GMP Auditing for the Pharmaceutical Industry (in development) | GMP Auditing for the Pharmaceutical Industry (in development) | GMP Auditing for the Pharmaceutical Industry (in development) | GMP Auditing for the Pharmaceutical Industry (in development) | GMP Auditing for the Pharmaceutical Industry (in development) | GMP Auditing for the Pharmaceutical Industry (in development)
 | Risk Management and Quality Management System (Quality Systems) | Design Construction an Installation (Facilities and Equipment) | Technology Transfer (Product Development) | Production Unit Operations (Production Systems) | Warehouse and Distribution Management (Supply Chain Management) | Controls and Automation (Facilities and Equipment)
 | Systems Validation (Quality Systems) | Commissioning and Qualification (Facilities and Equipment) | Production scale-up and optimization (Product Development) | Production Management (Production Systems) | Production Management (Production Systems)
 |  | Operation Maintenance (Facilities and Equipment) | Materials Management (Supply Chain Management) | Production Control (Production Systems)
 |  | Controls and Automation (Facilities and Equipment) |  | Operational Economics (Supply Chain Management)
 | Information Systems | Information Systems | Information Systems | Information Systems | Information Systems | Information Systems
 |  |  |  | Technology Transfer (Product Development)
ISPE COMMUNITIES OF PRACTICE
 | PPD | PPD | PPD | PPD | PPD | PPD
ISPE KNOWLEDGE BRIEFS
 | Concise, simple, and easy-to-read resources to help industry professionals get up to speed quickly on a wide variety of disciplines and topics.
ISPE MINI- REGULATION HANDBOOKS
 | Pharmaceutical (21 CFR 210/211) | Pharmaceutical (21 CFR 210/211) | Pharmaceutical (21 CFR 210/211) | Pharmaceutical (21 CFR 210/211) | Pharmaceutical (21 CFR 210/211) | Pharmaceutical (21 CFR 210/211)
 | Electronic Records; [NAME] | Electronic Records; [NAME] | Electronic Records; [NAME] | Electronic Records; [NAME] | Electronic Records; [NAME] | Electronic Records; [NAME]
 | Q8R - Pharmaceutical Development |  | Q7 - APIs
 | Q9 - Quality Risk Management
 | Q10 - Quality Systems
ISPE GUIDANCE DOCUMENTS
 | Our guidance publications take the collective knowledge of leading thinkers on manufacturing best practices, regulatory compliance and international trends and package it in an easy-to-use format you can easily apply to your work.