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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 Practices (GMP).
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
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 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 have immediate access to a certificate of completion in PDF format.

Benefits of Getting Certified at BioPharma Institute

At BioPharma Institute, our e-learning system comes with user-friendly learning tools like books, voiceovers, high-quality animations, progress checks, and more. This is used to assist our students in understanding the various learning concepts. It doesn't matter whether you are using one of our pharmaceutical training programs as a new employee or as a refresher course, you will find our online learning techniques to be useful, flexible, comprehensive, and effective.

If you or your company is seeking online training courses that are recognized across a wide range of industries, including healthcare, clinical research, biotechnology, and pharmaceuticals, BioPharma Institute is the company in which you can place your complete trust. For over two decades, we've been training employees from corporations of all sizes. The Institute has the capabilities to cater to large corporations and to those individuals seeking an upgrade in their skills and earning capacity.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


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.


COURSE OUTLINE:


Introduction
- 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

Conclusion
- Summary

COURSE OBJECTIVES:


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:


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

Full List of Programs in the Good Manufacturing Practices Catalog:



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

cGMP for Microbiology and Contamination Control Professional Certification Program: The GMP for Microbiology and Contamination Control Professional Certification Program offers a comprehensive overview of good manufacturing practice as it applies to contamination control and microbiology. It p ... Learn more

cGMP: An Introduction to Good Manufacturing Practice: This GMP course includes an introduction to current good manufacturing practices (cGMPs), information on maintaining product quality, the scope of GMP rules, a section on cleaning and sanitation, a look into pr ... Learn more

cGMP: Warehouse (Pharmaceuticals): The GMP for the Warehouse training program provides an overview and discussion of the role current good manufacturing practices has in the warehouse; and offers an emphasis in receipts, issues, storage, and dis ... Learn more

cGMP: Microbiology in the Workplace: The GMP: Microbiology In the Workplace training program offers a comprehensive overview of microbiology in the workplace, as it relates to current good manufacturing practices. The syllabus of this course inclu ... Learn more

cGMP: Cleaning and Sanitation: This Good Manufacturing Practice (GMP) in Cleaning and Sanitation training program offers a comprehensive overview and a solid introduction to cleaning and sanitation, as it relates to the regulator of quality ... Learn more

cGMP: Documentation and Record Keeping: This training program provides a comprehensive overview of current good manufacturing practices, with an emphasis on the role of proper documentation, and how it is used to provide a history of the manufacturin ... Learn more

cGMP: Contamination Control: This online training course offers a overview of good manufacturing practice with a comprehensive emphasis on contamination control. The program builds on microbiology in the workplace course, GMP03, and addres ... Learn more

cGMP: Production Controls: This program offers an overview of good manufacturing practice, with a comprehensive emphasis on production controls. The program builds on GMP06, the contamination control course. The course will describe and ... Learn more

cGMP: Packaging Controls: The good manufacturing practice in packaging controls program describes cGMP requirements for the control of packaging materials and operations. Students will explore the reasons that labeling problems still co ... Learn more

cGMP: Quality Assurance and Quality Control: 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 ... Learn more

cGMP: Pharmaceutical CAPAs: This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The ... Learn more

cGMP: Introduction to Good Manufacturing Practice, An Abridged Course: The cGMP: Introduction to Good Manufacturing Practice, An Abridged Course is a shortened training program used primarily for demonstration purposes only. The full length course includes an introduction to curre ... 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

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, or email Support@BiopharmaInstitute.com.

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