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Introduction To Good Manufacturing Practice (GMP)

Rated 5 out of 5
157
intro to GMP online training

Duration :

2

2 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:

Good Manufacturing Practice (GMP) sets the quality standards that pharmaceutical and medical device manufacturers must meet to satisfy regulatory requirements. This course covers the essentials, from facility and equipment management to documentation, quality systems, and compliance practices, giving you a solid foundation for working in GMP-regulated environments.

 
What you’ll learn?

  • Principles and scope of GMP in pharmaceutical manufacturing
  • Organize facilities and manage equipment for safe, efficient production
  • Implement documentation and quality management systems
  • Apply risk management, validation, audits, and compliance practices

 
Who should enroll?

  • Quality assurance and control professionals
  • Regulatory affairs specialists
  • Manufacturing, production, and laboratory personnel
  • Internal auditors and compliance teams

 
Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

 

Curriculum

Introduction: Good Manufacturing Practice (GMP): Definitions and Scope
Lesson 1: Importance Of Organization and Personnel in GMP
Lesson 2: Buildings, Surroundings, and Facilities
Lesson 3: Equipment
Lesson 4: Materials Management System
Lesson 5: Quality Management System
Lesson 6: Manufacturing Operations and Control
Lesson 8: Pharmaceutical Validation
Lesson 9: Outsourcing
Lesson 10: Post Operational Activities
Lesson 11: Site and Plant Security
Lesson 12: Pharmaceutical Audits
Lesson 13: Safety and Environmental Protection
Conclusion
Glossary
Quiz

Author:

Ellena Jefferson
Dr. Ellena J. Jefferson
Dr. Jefferson is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Dr. Jefferson is a fixer who continuously strives for excellence as a way of life; not just as a job.

Reviews:

Rated 5 out of 5
157
GMP guidelines present a better way of ensuring the quality of final products in manufacturing. Our team now understands that it is not as much the final evaluation of these products but a commitment to the highest possible standard of operation that maintains quality.
Alexander CarpenterDirector of QMS at Astellan Europe

$95

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

GxP-Training Benefits

  • Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
  • Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
  • Self-paced : access 24/7 to the course during 12 months at your own rhythm.
  • Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
  • Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
  • Instant Purchase : one click to buy and immediate access. Get certified today.
  • LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
  • HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
  • Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
  • LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.
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$95.00 / year

$95.00 / year

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