Length of Course: Approximate time to complete this course is 2 hour(s).
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: Master Plans and Documentation
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 effective validation of master plans and documentation. The entire program must be viewed by students. In order to pass, an 80% or better score on a multiple-choice, online final assessment is required.
Course objectives include the following: Demonstrate how to apply the change control program to maintain items in a validated state, to show how to develop and publish validation document, to illustrate how to prepare a responsibility matrix and validation schedule, to demonstrate how to determine the content and scope of a VMP, and to explain why a VMP is important to validation management.
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.
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. The BioPharma Institute has both the course content and experience required to deliver the high-quality training that your colleagues, your employees, and you could use to succeed in achieving corporate objectives and advancing careers. Our proven techniques can assist you and your company in your biotechnology, pharmaceutical, and healthcare educational needs.
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: Master Plans and Documentation course is found in the following professional certification program(s):
VALIDATION MASTER PLAN
2. First Class Pharmaceuticals
4. Definitions and standards
5. The new line
6. Glossary of terms
7. VMP Structure
8. Importance of VMP
9. VMP and responsibilities
10. Regulatory requirements
11. VMP sections
12. VMP content
SCOPE OF THE VMP
16. Using risk assessment
17. Defining risk
18. Critical vs non-critical
19. Risk assessment approach
20. Validation strategy
21. Validation policies
22. Qualification phases
23. Equipment qualification
24. Developing a plan
28. Documentation overview
30. Reference documents
31. Authorizing validation
32. Organizing validation
33. Using protocol templates
34. Change control
35. Required procedures
36. Handling deviations
37. Validation data
38. Tracking and cataloguing
39. Archiving and retrieving
40. Report and certification
44. Change management
45. Reporting rules
Explain why a VMP is important to validation management.
Determine the scope and content of a VMP.
Prepare validation schedules and a responsibility matrix.
Develop and publish validation documentation.
Apply the change control program to maintain items in a validated state.
All Courses in the Validation for BioPharma Companies Catalog:
|Validation: Principles/International Regulations: This online training program offers an introduction to the principles behind and the international regulations to assure effective qualification and validation. The entire program must be viewed by students. In ... Learn more|
|Validation: Master Plans and Documentation: This online program offers an introduction to the international principles and regulations behind effective validation of master plans and documentation. The entire program must be viewed by students. In order ... Learn more|
|Validation: Commissioning and Installation Qualification: This online program offers an introduction to the international principles and regulations behind commissioning and installation qualification (IQ). The entire program must be viewed by students. In order to pa ... Learn more|
|Validation: Operational/Performance Qualification Protocols: This online program offers an introduction to operational qualification (OQ) and performance qualification (PQ). The entire program must be viewed by students. In order to pass, a multiple-choice, online final ... Learn more|
|Validation: Equipment Cleaning Validation: 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% o ... Learn more|
|Validation: Computer Systems - Part I: This online program offers an introduction to the international principles and regulations behind computer systems validation. Course objectives include the following: to offer an understanding the computer sys ... Learn more|
|Validation: Computer Systems - Part II: This online training program builds upon Computer Systems Validation Part l (VAL09). It offers an introduction to computer systems validation as required by GxP regulations. Course objectives include the follow ... 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
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.