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Tuesday, December 11, 2018
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Validation: Equipment Cleaning Validation (VAL08)

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: Validation for BioPharma Companies.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

BioPharma Institute LogoTraining Program: Validation: Equipment Cleaning Validation
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This online program offers an introduction to the international principles and regulations behind equipment cleaning validation. The entire program must be viewed by students. In order to pass, a score of 80% or better is necessary on a multiple-choice, online final assessment.

Course objectives include the following: To analyse cleaning validation results and the preparation of reports, to develop and execute cleaning validation protocol, to determine your criteria on ‘How Clean Is Clean?’, to offer a definition of cleaning validation prerequisites, to explain the factors that determine your cleaning validation scope, and to explain regulatory requirements and a definition of cleaning validation terminology.

Once all course requirements have been satisfied, a certificate of completion is immediately available in PDF format. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade. Following a brief introduction, topics covered in this course include acceptance criteria, prerequisites, scope, report document, writing protocols, and a conclusion that summarizes the previously listed topics.

Benefits of Getting Certified at BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. Through new automated tracking systems and the application of advanced e-learning training techniques, the BioPharma Institute is helping companies by offering online education to their employees, the maintaining of training records, and assisting them in an overall improvement in the quality of service they offer.

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 Validation: Equipment Cleaning Validation course is found in the following professional certification program(s):


Pharmaceutical Validation Management Professional Certification Program: This online professional certification program includes an introduction to the principles behind the international regulations of effective validation and qualification. Additionally, it introduces the internat … Learn more


COURSE OUTLINE:


INTRODUCTION
1. Outcomes
2. Meet the V team
3. Introduction
4. Worst-case scenario
5. The new line
6. Definitions
7. Review I
8. Summary
9. Review II
SCOPE
10. Introduction
11. Two approaches
12. SOP validation
13. SOP requirements
14. Classifying equipment
15. What to validate I
16. What to validate II
17. Common equipment
18. Bracketing
19. Cleaning requirements
20. CIP qualification
21. Using previous data
22. Testing surface residues
23. Microbial limits and residues
24. Summary
25. Review
PRE-REQUISITES
26. Analytical techniques
27. LOD and LOQ
28. Swab recovery studies I
29. Swab recovery studies II
30. Visual inspection
31. Role of flush sampling
32. Summary
33. Review
ACCEPTANCE CRITERIA
34. Introduction
35. How clean is clean?
36. Worst-case products I
37. Worst-case products II
38. Toxicity study
39. Considerations I
40. Considerations II
41. Maximum Daily Dose
42. Surface residue limits
43. Calculating SAL
44. Summary
45. Review
WRITING PROTOCOLS
46. Introduction
47. Worst-case conditions
48. Sampling locations
49. Applying the protocol
50. Are we prepared?
51. Documenting results
52. Summary
53. Review
REPORT DOCUMENT
54. Introduction
55. On-going requirements
56. Review
CONCLUSION
57. Summary

COURSE OBJECTIVES:


–Define cleaning validation terminology and explain regulatory requirements.
–Explain the factors that determine your cleaning validation scope.
–Define cleaning validation pre-requisites.
–Determine your criteria for ‘How Clean is Clean’.
–Develop and execute cleaning validation protocol.
–Analyze cleaning validation results and prepare reports.


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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