GMP Essentials for Virtual Companies Ensuring Compliance

The price of the eLearning is $150 USD but we are offering an introductory rate of $99 USD until 31 March 2025

The course delivers actionable insights into GMP fundamentals for virtual companies, emphasizing the critical responsibilities of Marketing Authorization Holders (MAH) and Manufacturing Import Authorization (MIA) holders. Participants will learn to foster a strong quality culture, manage outsourcing effectively, and address the complexities of batch release in virtual environments. Additionally, learners will gain insights into data integrity practices and stay updated with the latest regulatory changes to ensure compliance.

Participants will engage with knowledge checks and complete a competency assessment to reinforce learning. Successful completion awards a certificate of completion, showcasing your proficiency in GMP essentials for virtual companies.

Upon completing the course, participants will be able to:

• Describe the responsibilities of a Marketing Authorization Holder (MAH) and a Manufacturing Import Authorization (MIA) holder and express the importance of GMP.
• Review the term "quality culture" and how the FDA’s Quality Maturity Model (QMM) may enhance the Pharmaceutical Quality System (PQS).
• Consider the importance of training as a component of GMP.
• Analyze the challenges involved in outsourcing management.
• Identify the QP challenges and the batch release process in a virtual company.
• Examine the value of staying current with regulations including data integrity requirements to remain compliant.
• Explain why quality metrics are essential to quality oversight.

This course is tailored for regulators and professionals in virtual pharmaceutical companies seeking practical strategies to navigate GMP requirements and ensure compliance in a virtual operating model.