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Sunday, December 16, 2018
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cGMP: Production Controls (GMP07)

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: Production Controls
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

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 define starting material controls, dispensing controls, processing controls, process monitoring, and handling deviations. Most importantly, the course will address the proper actions to be taken when confronted with materials that are nonconforming. The course objectives cover how to perform reconciliation and yield calculations, the purpose of clearance procedures, and why strict manufacturing controls are needed. Once all course requirements have been satisfied you will immediately receive a certificate of completion via PDF.

Benefits of Getting Certified at BioPharma Institute

Throughout many of our courses, students engage in active learning with the assistance of tools like videos, seminars (both recorded and live), online books, and more. At BioPharma Institute, we have the ability to cater to not only small-scale training, but large-scale training requests. Our capabilities include customizing training in a manner that meets with corporate or individual requirements. We offer programs that will train teams economically, and without the need for missing a full day of work in order to attend a day-long class.

For more than two decades we have provided solutions in online training for thousands of organizations in industries such as biotechnology, clinical research, pharmaceutical, and healthcare. Businesses can now train their employees without having to allocate time during which to conduct live classes, thanks to the more flexible scheduling offered by convenient e-learning courses.

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: Production Controls 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. Production controls
3. What you will learn
4. Outcomes
STARTING MATERIAL CONTROL
5. Starting material
6. Receiving
7. Receiving II
8. Sampling and testing
9. Status labeling
10. Storage
11. Storage II
12. Issue
DISPENSING CONTROL
13. Dispensing controls
14. Room clearance
15. Setup
16. Dispensing
17. Dispensing II
18. Clean-up
19. Review
20. A dispensing step
PROCESSING CONTROL
21. Processing
22. Room clearance
23. Room clearance II
24. Formulation controls
25. In-process checks
26. In-process checks II
27. Batch records
28. Batch records II
29. Clean-up
PROCESS MONITORING
30. Process monitoring
31. Exercise
HANDLING DEVIATIONS
32. Handling deviations
33. Handling deviations II
YIELD
34. Yield
35. An example
36. An example II
CONCLUSION
37. Summary
38. Summary II

COURSE OBJECTIVES:


The need for strict manufacturing controls.
The purpose of room clearance procedures.
How to perform yield and reconciliation calculations.


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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