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GMP: Good Manufacturing Practices

Certification Training
 
Rated 4.67/5
3 reviews
Program/Course ID: ELM-103
Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Good Manufacturing Practice (cGMP).
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $199.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: GMP: Good Manufacturing Practices
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
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 course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


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

Pharmaceutical Quality System (PQS) / 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

Objectives:


Skill Level:
Basic

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

GMP: Good Manufacturing Practices is included in the following professional certification programs:



Training Program For Professionals:

cGMP for Intermediate Professionals

Course ID: GMPINTP
Price: $845.00 (USD) | Learn more

Professional Certification Program:

US Medical Device Quality Assurance (QA) Professional Certification Program

Course ID: QADPRO
Price: $2295.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Purchase orders (POs): If a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • 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.
  • 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 requirements have been fulfilled.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.