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Friday, June 18, 2021
Home » GMP: Good Manufacturing Practices

GMP: Good Manufacturing Practices (ELM-103)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 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: Good Manufacturing Practices
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 ReviewsThis accredited online training course will teach you about Good Manufacturing Practice (cGMP) which is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
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: Good Manufacturing Practices 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?
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 - Sulphanilamide
1940 - Contaminated Caps - Lambert
1955 - Polio Vaccine
1962 - Thalidomide
Why GMP is so Important?

GMP Regulations
Overview
GMP Regulations & Guidelines
GMP's in Different Countries
WHO
ICH
EMEA
MHRA
USFDA
GMP concept
What aspects of manufacturing does cGMP cover?
Review activity

Quality Management System (QMS)
Overview
What is Quality Management?
Standard Operating Procedures (SOP)
Quality Objective
GMP as a part of Quality Assurance
Requirements for an effective QA program
ICH Q10
Life Cycle Phases of GMP

Premises
Overview
Premises
Production Areas
Changing Rooms
Storage Areas
Quality Control Areas

Personnel
Overview
Personnel
General Principles
Staff Product Contact Requirements
Grades A,B,C & D
Personal Hygiene
General considerations for manufacturing areas
Review activity

Changes to Equipment
Overview
Equipment
Balances
Utilities
Documentation
Change control

Qualification & Validation
Overview
Definitions
Qualification Vs Validation
Risk Assessment
Types of Validation Documentation

Complaints and Product Recalls
Overview
Complaints and product recalls
Classification of defects - critical
Classification of defects - major
Classification of defects - minor
Product recall procedures

Self-Inspection
Production Practices

Quality Control

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.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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