GMP for Pharmaceutical Packaging and ISO 15378

5/5
4
GMP for Pharmaceutical Packaging and ISO15378

Duration :

1

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

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.

Description:

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:

  • Understanding packaging components and their role in product safety.
  • Navigating key requirements from global regulations (FDA, ISO 15378, and EU guidelines)
  • Managing packaging design and artwork processes effectively.
  • Optimizing packaging processes and operations for quality and efficiency.
  • Evaluating packaging materials and suppliers to meet GMP standards.

 

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. 

 

Curriculum:

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

Author:

ciaran
Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience. Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

5/5
4
USD: United States (US) dollar ($) ^

$95

Buy now

  Large group ? Request a quote !

This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

[finale_countdown_timer campaign_id="40465" skip_rules= "yes"]

$95.00 / year

$95.00 / year

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course