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Validation: Equipment Cleaning Validation (VAL08)

Certification Training
 
Rated 4.38/5
8 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

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

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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 training objectives include: To analyze cleaning validation results and the preparation of reports, to develop and execute cleaning validation protocol, to determine your criteria on cleanliness, 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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


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.

The Validation: Equipment Cleaning Validation Course is Included in the Following Professional Certification Programs:


Pharmaceutical Validation Management Professional Certification Program: This professional certification program includes an introduction to the principles behind the international regulations assuring effective validation and qualification procedures, commonly referred to as Good V ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

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.

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