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cGMP: Production Controls (GMP07)

Certification Training
 
Rated 4.44/5
9 reviews
Duration: 2 hours, Online (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. BioPharma Institute Reviews

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):


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.

All Courses in the Good Manufacturing Practices Catalog:


cGMP: Documentation and Record Keeping, An Abridged Course: The GMP: Documentation and Record Keeping, an Abridged Course, is a shortened course used for demonstration purposes only. The full length course poses the questions: Can you withstand an FDA audit? How familia ... Learn more

cGMP: An Introduction to Good Manufacturing Practices: 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: 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

Online Training: The Benefits of eLearning

  • 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
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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