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Sunday, December 16, 2018
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cGMP: An Introduction to Good Manufacturing Practices (GMP01)

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: An Introduction to Good Manufacturing Practices
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

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 proper documentation, and concludes with a summary. The course will explore a list of essential packaging and production controls, review of guidelines describing the proper way to execute GMP records, examines the GMP personal hygiene requirements, clarifies the four key product quality attributes, describes the purpose of GMP codes and regulations, and offers explanations of why companies implement GMP. Once all course requirements have been satisfied a Certificate of Completion is immediate available in PDF format.

Benefits of Getting Certified at BioPharma Institute

The BioPharma Institute’s objective is to assist professionals in a way that allows them to uncover new discoveries, and help further their understanding of a chosen industry and the peripheral technologies contained within it. We assist companies through the education of their employees, the maintaining of records which pertain to training, and by helping them achieve an overall improvement in the quality of service they offer.

BioPharma Institute uses, among other methods, new automated tracking systems and advanced e-learning training techniques in the pursuit of teaching you, your colleagues, and/or your employees. The courses offered will assist students with how to achieve personal objectives and how to succeed in their careers.

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: An Introduction to Good Manufacturing Practices 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

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


COURSE OUTLINE:


INTRODUCTION
1. Welcome
2. Objectives
3. Reviews and assessments
4. What do you think?
5. GMP solution
6. Events that have shaped GMP
7. Evolution of GMP
8. The introduction of codes of GMP
9. Regulatory agencies around the world
10. FDA, MHRA/EMEA, TGA
11. PIC/S
12. What does GXP mean?
13. Review

PRODUCT QUALITY
14. What do you think?
15. GMP solution
16. Overview
17. What is quality?
18. Protecting consumers with GMP rules
19. Quality management
20. Quality assurance
21. Quality control
22. Review

SCOPE OF GMP RULES
23. What do you think?
24. GMP solution
25. Scope of GMP codes
26. Self inspection/internal audits
27. GMP compliance program
28. Personnel & training
29. Equipment & GMP
30. Facility & grounds
31. Manufacturing & GMP
32. Manufacturing controls
33. Review

CLEANING & SANITATION
34. What do you think?
35. GMP solution
36. GMP & housekeeping
37. Cleaning & sanitation
38. Personal hygiene & GMP
39. Personal hygiene programs
40. Review

DOCUMENTATION
41. What do you think?
42. GMP solution
43. GMP and documentation
44. GMP & manufacturing records
45. Rules for completing records
46. Exercise
47. Review

CONCLUSION
48. Summary

COURSE OBJECTIVES:


– Explain why your company has implemented GMP
– State the purpose of GMP regulations and codes of GMP
– State the four key product quality attributes
– State the GMP requirements for personal hygiene
– Describe the correct way to complete GMP records
– List the essential production and packaging controls


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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