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Home » GMP: Cases from History and the Regulations

GMP: Cases from History and the Regulations (ELM-201)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~30 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Good Manufacturing Practice (cGMP).
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GMP: Cases from History and the Regulations
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsIn this course we will discuss some of the cases from history where the lack of GMP caused devastating effects for patients using medicines. Through the use of real life case studies, it should be very apparent how important it is to take GMP seriously. We will also cover how GMPs differ in other countries and what aspects of manufacturing does GMP not cover.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


GMP: Cases from History and the Regulations course is included in the following Professional Certification Programs:



cGMP for Intermediate Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Overview
Learning objectives
Who should take this course
Program introduction
Module overview

The Starting Line
Overview
What is GMP
What is cGMP
World Health Organization (WHO)
Why GMP?

Cases From History
Overview
Cases from history
1930 - Lubeck BCG Vaccine
1938 - Sulpanilamide
1940 - Contaminated Caps (Lambert, E.C)
1955 - Polio vaccine (Cutter Laboratories)
1962 - Thalidomide
Why GMP is so important?

GMP Regulations and the Guidelines
Overview
GMP regulations and guidelines
How do GMP's different in other countries
WHO
ICH
EMEA
MHRA
US FDA
GMP concepts
What aspects of manufacturing does GMP cover

Conclusion


Final Exam


Certification


COURSE OBJECTIVES:


Skill Level:
Basic

This training program has been developed to train employees with Basic Knowledge of Good Manufacturing Practices (cGMP).

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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