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: Validation for BioPharma Companies.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $195.00
Training Program: Validation: Equipment Cleaning Validation
Training Provided By: BioPharma Institute
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.
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 Validation: Equipment Cleaning Validation course is found in the following professional certification program(s):
2. Meet the V team
4. Worst-case scenario
5. The new line
7. Review I
9. Review II
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
19. Cleaning requirements
20. CIP qualification
21. Using previous data
22. Testing surface residues
23. Microbial limits and residues
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
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
47. Worst-case conditions
48. Sampling locations
49. Applying the protocol
50. Are we prepared?
51. Documenting results
55. On-going requirements
--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.
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
- 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
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.