GMP & Compliance Series

Introduction to Good Manufacturing Practices (GMP) - Level 1

This introductory GMP course examines the history, rationale, purpose, and GMP requirements applicable to the manufacturing, packaging and labeling, testing, and control of pharmaceutical products and consequence of inaction.

Gain practical knowledge in understanding of the essential elements of GMP and a compliant quality system required for employment with the pharmaceutical industry.

Purchase all 3 modules for $375 +HST (a saving of $30!) REGISTER NOW

MODULE 1 (GMP1001.1) -
prerequisite none

Session 1 - Introduction to GMPs
Session 2 - Essential Elements of GMPs
Session 3 - People and Product
Session 4 - Premises


Price: $135 +HST

MODULE 2 (GMP1001.2) -
prerequisite module 1

Session 5 - Documentation
Session 6 - Standard Operating Procedures (SOPs)
Session 7 - Non-Conformances


Price: $135 +HST

MODULE 3 (GMP1001.3) -
prerequisite module 2

Session 8 - Validation
Session 9 - Change Control
Session 10 - Maintenance Quality Audits



Price: $135 +HST



Good Manufacturing Practices - Quality System Design - Level 2

The course is designed to address the need for a working knowledge of design and development of a strong and compliant quality system. Case studies and student workshops on Quality management tools such as change management, failure investigation, laboratory control system, validation system, and stability program provide graduates with the sound and applicable knowledge needed to perform their job responsibilities confidently

Purchase all 3 modules for $375 +HST (a saving of $30!) REGISTER NOW

MODULE 1 (GMP2001.1) -
prerequisite none

Session 1 - Review of GMP 1 - GMP Compliance, Practices, Law and Ethics
Session 2 - Quality System Tools
Session 3 - Lab Controls
Session 4 - Out of Specifications/Trending

Price: $135 +HST

MODULE 2 (GMP2001.2) -
prerequisite module 1

Session 5 - Change Control and Deviation Control System
Session 6 - Stability System Compliance
Session 7 - Validation Requirements



Price: $135 +HST

MODULE 3 (GMP2001.3) -
prerequisite module 2

Session 8 - Quality Management
Session 9 - Complaints and Adverse Reactions
Session 10 - Self Audits and Government Inspections
Session 11 - Review

Price: $135 +HST



Good Manufacturing Practices - A Global Perspective - Level 3

The third in our GMP series, this course takes an advance look at global GMP and other international regulatory guidelines, policies and expectations. The course recognizes the important role of various international regulatory standards, guidelines, and agreements such as ISO 9000 series, SUPAC, ICH, and MRA. It examines in detail the latest international and FDA's regulatory requirements, policies, procedures and trends.

Purchase all 3 modules for $375 +HST (a saving of $30!) REGISTER NOW

MODULE 1 (GMP3001.1) -
prerequisite none

Session 1- Introduction
Session 2 - Validation Requirements
Session 3 - FDA and European GMPs



Price: $135 +HST

MODULE 2 (GMP3001.2) -
prerequisite module 1

Session 4 - ICH and PIC Guidelines
Session 5 - HPFBI Annexes to the GMP
Session 6 - HPFBI Guidelines



Price: $135 +HST

MODULE 3 (GMP3001.3) -
prerequisite module 2

Session 7 - Natural Health Products
Session 8 - Sterile Products
Session 9 - Pharmaceutical Air Systems



Price: $135 +HST



Writing of GMP Documentation - Change Control, Non-Conformances, SOP, Protocol...

This course covers the essential elements of developing Standard Operating Procedures (SOP), Records of Training, Batch documents, Change Control, Stability documents, deviation and investigation reports.

Purchase all 3 modules for $465 (a saving of $30!) REGISTER NOW

MODULE 1 (TWR3008.1) -
prerequisite none

Session 1 - General Overview of Key Documents
Session 2 - Standard Operating Procedure (how to write them)



Price: $165 +HST

MODULE 2 (TWR3008.2) -
prerequisite module 1

Session 3 - Change Control
(how to write them)
Session 4 - Deviations (how to write them)
Session 5 - Stability Programs and Protocols
Session 6 - Method Validation Protocols and Reports

Price: $165 +HST

MODULE 3 (TWR3008.3) -
prerequisite module 2

Session 7 - OOS Investigation Reports
Session 8 - Certificate of Manufacture
Session 9 - Monthly Reports
Session 10 - Responding to GMP Citation
Session 11 - Correspondence & Communication

Price: $165 +HST