To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work together, and establishes performance specifications. The Quality System provides mechanisms to monitor and control processes, systems, and people to ensure the highest level of safety, quality, and efficacy. In this On Demand course (part 3 of 11), you will learn the elements of a Quality System, as required by regulation.
Included in the GMP Refresher Certificate Program
The ISPE Academy’s comprehensive GMP Certificate program includes a mandatory GMP refresher course and allows learners to customize their learning experience by selecting two out of eleven GMP Fundamentals modules. Learn More and Register
Interactive Course: What to Expect
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.
Benefits include:
Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
Member-only discounts on Guidance Documents, Conferences, and Training
Pharmaceutical Engineering® magazine
Communities of Practice access to pharma professionals in specific topics from around the world
ISPE training is priced using Global Access Pricing, a four-tier model designed to reflect what a course actually costs in your country, not just what the US price converts to.
Because course fees vary, tiered rates are applied as a percentage of the standard US price. Your rate is calculated automatically at registration based on your country, and applies to both member and non-member pricing.
Global Pricing is only for Instructor Led Training.
Tier
Member
Non-member
Tier 1
Standard pricing
Standard pricing
Tier 2
US$ 620
US$ 805
Tier 3
US$ 454
US$ 575
Tier 4
US$ 300
US$ 345
Example: Rates shown are based on a course listed at US$ 2,000 for members and US$ 2,300 for non-members. Actual amounts vary by course.