Home / Online GXP courses / GMP : Good Manufacturing Practices / GMP for Pharmaceutical Packaging and ISO 15378
Successful completion provides learners with a dated, traceable and downloadable certificate for the course :
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
ISO 15378 is a standard that applies Good Manufacturing Practices (GMP) principles to the production of direct packaging materials for medicinal products. It outlines the requirements for a quality management system specifically designed for this purpose.
This standard combines the core elements of ISO 9001:2015 with additional requirements adapted from GMP guidelines. These include provisions for production processes, quality control, risk management, and traceability to meet the stringent needs of the pharmaceutical industry.
Primary packaging materials such as glass, rubber, aluminum, or plastic that come into direct contact with the pharmaceutical product are covered. Manufacturers of pharmaceutical packaging ensure compliance with national, European, international, and American (FDA) legal requirements.
Who should enroll?
This course is perfect for professionals working in pharmaceutical packaging, quality assurance experts, and regulatory affairs specialists. It’s also valuable for managers overseeing packaging operations and anyone eager to enhance their knowledge of GMP practices to ensure both compliance and the safety of pharmaceutical products.
Topics outlined in the course:
Each session integrates real-life examples and assessments to facilitate a comprehensive and applied learning experience. Upon completion, participants will receive a globally acknowledged GMP for Pharmaceutical Packaging training certificate, accredited with CPD/CEU credits.
Introductory Video
Lesson 1: Packaging Components
Lesson 2: Regulatory and GMP Requirements
Lesson 3: Packaging Design and Artwork Management
Lesson 4: Packaging Process and Operations
Lesson 5: Testing and Evaluation of Packaging Materials
Lesson 6: Supplier and Quality Considerations
Conclusion
Evaluation
$95.00 / year
$95.00 / year
© GxP Training 2021