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Sunday, December 16, 2018
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cGMP: Quality Assurance and Quality Control (GMP09)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
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

BioPharma Institute LogoTraining Program: cGMP: Quality Assurance and Quality Control
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

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 >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, password and receipt of payment 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 training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The cGMP: Quality Assurance and Quality Control course is found in the following professional certification program(s):


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


COURSE OUTLINE:


INTRODUCTION
1. Introduction
2. What you will learn
3. Outcomes
4. QA, GMP and QC
QUALITY CONTROL
5. Quality Control
6. QC sampling and testing
7. QC and specifications
8. Sampling plan procedure
9. Review I
10. Sampling limitations
11. Review II
12. GLP
13. Review III
GMP AND VALIDATION
14. GMP and validation
15. GMP requirements
16. What is GMP about?
17. What is validation?
18. Benefits of validation
19. What needs to be validated?
20. Environment
21. Personnel
22. Methods
23. Machines
24. Materials
25. Measurement
26. In-process control
27. Review
QUALITY ASSURANCE
28. Quality Assurance
29. GMP internal audit
30. Control over manufacturing changes
31. Vendor assurance
32. GMP & process deviation
33. Release for supply
34. Review
QUALITY PRINCIPLES
35. Quality principles I
36. Quality principles II
37. Importance of training
38. GMP training
39. Knowledge
40. Quality people & customers
SUMMARY
41. Summary I
42. Summary II
43. Summary III
44. Summary IV

COURSE OBJECTIVES:


The complimentary roles of Quality Assurance and Quality Control.
The purpose of GMP auditing.
The role of process validation.
The limitations of quality control testing.
The purpose of Release for Sale.


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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