cGMP: Production Controls (GMP07)
 | Duration: 2 hours, Online (the average time to complete the training program, including final assessments). Credits Hours: 2Self-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 
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 Training Program: cGMP: Production ControlsTraining 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. The cGMP: Production Controls course is found in the following professional certification program(s):
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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. | |
Online Training Program Benefits:
- Immediate access to training: Instructions, username, 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 courses: 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
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- 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
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization
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.
