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cGMP: Quality Assurance and Quality Control (GMP09)

Certification Training
Rated 4.11/5
9 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: 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: cGMP: Quality Assurance and Quality Control
Training Provided By: Biopharma Institute

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

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

This course emphasizes quality assurance and quality control, with respect to good manufacturing practices. Participants explore GMPs as they apply to quality testing, management, manufacturing, and the control of pharmaceutical products. The objectives of this course are to describe the importance of the release for sale, the limitations of quality control testing, process validation and its role, GMP auditing and its purpose, quality control and quality assurance control, and their complementary roles.

Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate cGMPs and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.

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.


- Objectives
- Reviews and assessment
- Overview

Quality principles
- What do you think?
- What do the GMP rules state?
- What is quality?
- Fundamental GMP rules
- Responsibility for quality
- Knowledge and behavior

Pharmaceutical Quality System (PQS)
- PQS model
- Key PQS elements
- Management responsibility
- Quality functions within a PQS

Quality Assurance (QA)
- What do you think?
- What do the GMP rules state?
- Overview
- Vendor assurance
- Documents and records
- Traceability
- Training
- Internal audits / self inspections
- Types of audits
- CAPA definitions
- CAPA systems
- CAPA phases
- Change management (change control)
- Deviations
- Release for supply
- Release for supply checks

Quality Assurance (QA) (continued)
- True or false?
- Vendor assurance is...
- Select all that apply for GMP compliant documents

Good Manufacturing Practice (GMP)
- What do you think?
- What do the GMP rules state?
- Overview
- Scope of GMP rules
- Documentation and records
- Introduction to validation
- Cleaning validation (example)
- Process control
- Contamination control
- Which documentation provides information on whether or not a process remained in control?
- True or false?
- Select all options that need validating?

Quality Control (QC)
- What do you think?
- What do the GMP rules state?
- Overview
- QC responsibilities
- Good (Quality Control) Laboratory Practices
- Laboratory documentation system
- Sampling
- Reliable test methods
- Specifications
- Checking results
- Limitations
- Select all options that QC is responsible for
- Is there inherent risk in conclusions from sample results?
- Fill in the blanks

- Summary


This module provides an introduction to the functions of Quality Assurance (QA) and Quality Control (QC) in the effective and safe production and control of medicinal products.

- Recognize how attention to manufacturing quality products reflects on daily operations.
- Identify the role of QA in pharmaceutical manufacturing
- Recognize how companies use GMP rules to minimize errors in manufacturing
- Identify main roles & responsibilities of QC
- Recognize the key elements of a PQS

The cGMP: Quality Assurance and Quality Control Course is Included in the Following Professional Certification Programs:

Quality Control in the Laboratory Professional Certification Program: The Quality Control in the Laboratory Professional Certification Program is an online program offered by Biopharma Institute. The program provides training on the current standards governing lab professionals a ... Learn more

Current Good Manufacturing Practice (cGMP) Professional Certification Program: The Current Good Manufacturing Practice (cGMP) Professional Certification Program provides a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for ph ... Learn more

Online Training: The Benefits of 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 requirements.
  • 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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