GMP Refresher Course 2023

As a pharmaceutical professional, it’s essential to stay up-to-date with the latest regulatory guidance and best practices to ensure the safety and quality of your products. It is also a requirement in all GMP regulations that all personnel working in such facilities are required to undertake continuing periodic training and assessment on the relevant duties assigned.

However, finding the time and resources to attend GMP refresher courses can be challenging. Our online on-demand GMP refresher course is the perfect solution for busy professionals who need to stay up-to-date with the latest regulatory guidance and best practices.

Our video-based course covers all the essential topics, from basic concepts to the latest trends in regulatory guidance and hot topics like deviations and effective QMS. And best of all, our course is flexible and accessible on-demand, so you can fit training into your busy schedule without disrupting your work or personal life.

Don’t let scheduling challenges hold you back from prioritizing your education and ensuring compliance and quality in the pharmaceutical industry.

Additionally, you will be eligible for our Q&A and monthly regulatory updates and discussion sessions with our Expert, Charley Maxwell.

Sign up for our comprehensive online on-demand GMP refresher course today and take control of your knowledge and skills in the field.

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Introduction

1
GMP Refresher Course Intro Video
2 minutes

Introduction

1
GMP Refresher Course Intro Video
2 minutes

What is GMP?

1
Chapter Overview
2
Chapter Overview
3
Video Lesson – What is GMP?


4
Video Lesson – What is GMP?


5
Chapter Summary
6
Chapter Summary

Basic Concepts of GMP

1
Video Lesson - Basic Concepts of GMP
2 minutes
2
Chapter Summary
1 minute

Recent trends in Regulatory Guidance

1
Chapter Overview
2
Chapter Overview
3
Video Lesson- Recent Trends in GMP
4 minutes

This video covers recent trends in regulatory guidance, such as the need for product identification numbers to verify the authenticity and the growing need for harmonization and cooperation between regulatory agencies. It also discusses mutual recognition agreements and their impact on GMP compliance.

4
Video Lesson- Recent Trends in GMP
4 minutes

This video covers recent trends in regulatory guidance, such as the need for product identification numbers to verify the authenticity and the growing need for harmonization and cooperation between regulatory agencies. It also discusses mutual recognition agreements and their impact on GMP compliance.

5
Chapter Summary
3 minutes
6
Chapter Summary
3 minutes
7
Quiz
3 questions
8
Quiz
3 questions

Recent Regulatory Changes

1
Section Overview
2
Changes to Veterinary Regulations
1 minute
3
Changes to Clinical Trials Regulations
2.5 minutes
4
CDER Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
1 minute
5
Risk Management Plans to Mitigate the Potential for Drug Shortages
1 minute


6
Non-Penicillin Beta-Lactam Drugs- A cGMP Framework for Preventing Cross-Contamination
1 minute
7
Update to EU-GMP Annexes
3 minutes
8
Chapter Summary
3 minutes
9
Quiz - Recent trends in Regulatory Guidance
2 questions

Basic Concepts of GMP

1
Video Lesson - Basic Concepts of GMP
2 minutes
2
Chapter Summary
1 minute

Regulatory Hot Topic 1: Deviations or Non-conformance Investigations

1
Section Overview
2
How Deviations Are Defended by Regulators
2 minutes
3
How Deviations Are Defended by Regulators
2 minutes
4
How to Document Deviations
2 minutes
5
Steps in the Deviations Life-Cycle
1 minute
6
Immediate Actions
1.5 minutes
7
How to Document Deviations
2 minutes
8
Investigation of Deviations
1.5 minutes
9
Immediate Actions
1.5 minutes
10
Quiz - Deviations or Non-conformance Investigations
3 questions
11
Investigation of Deviations
1.5 minutes
12
Corrective and Preventive Actions (CAPAs)
1 minute
13
Chapter Summary
6 minutes
14
Quiz - Deviations or Non-conformance Investigations
3 questions

Recent Regulatory Changes

1
Section Overview
2
Changes to Veterinary Regulations
1 minute
3
Changes to Clinical Trials Regulations
2.5 minutes
4
CDER Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
1 minute
5
Risk Management Plans to Mitigate the Potential for Drug Shortages
1 minute


6
Non-Penicillin Beta-Lactam Drugs- A cGMP Framework for Preventing Cross-Contamination
1 minute
7
Update to EU-GMP Annexes
3 minutes
8
Chapter Summary
3 minutes
9
Quiz - Recent trends in Regulatory Guidance
2 questions

Regulatory Hot Topic 2: Effective QMS Procedures

1
Section Overview
2
Section Overview
3
Intro to SOPs
2 minutes
4
Intro to SOPs
2 minutes
5
Control and Accessibility of SOPs
1 minute
6
Control and Accessibility of SOPs
1 minute
7
Chapter Summary
3 minutes
8
Chapter Summary
3 minutes

Final Test

1
Final test
16 questions
2
Final test
16 questions
Yes, every student who finishes the course and passes the test will get a certificate of accomplishment.
Yes, we can help you enroll groups in the course and allow wire payment with easy invoicing. Please contact us at service@qualistery.com.
Once purchased, you can access the courses for an unlimited time.

All course participants will gain access to monthly exclusive sessions with Charley Maxwell on regulatory updates. During the sessions, you can ask questions and exchange information.

Get course
Enrolled: 112 students
Duration: 1.5-2 hours
Lectures: 54
Level: Intermediate
GMP Refresher Course 2023
Price:
€125 €85

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