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: Principles/International Regulations
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
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 order to pass the course, students must achieve a passing grade of 80% or more on the online, multiple choice final assessment.
Course objectives include the following: To provide a description of the V-model approach to validation, to list the scope of validation, to description of the roles of a validation team and the difference between noncritical and critical equipment - in terms of validation activities, to detail the reasons for validation, to describe the development of regulatory control and validation, and to define some important validation terms.
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. No matter how big or small, the BioPharma Institute can handle the refreshment course or training needs of your company. Let us share our experience, high-quality course content, and proven techniques with you and your employees to further the understanding of the requirements pertaining to the pharmaceutical, biotechnology, and healthcare industries.
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: Principles/International Regulations course is found in the following professional certification program(s):
2. First Class Pharmaceuticals
4. New liquids line
5. Definition of validation
6. Equipment qualification
7. Process validation
8. Process control
9. Glossary of terms
10. NA regulations
11. PICS/EU/TGA regulations
15. History of validation
17. Current trends
18. Applying risk assessment
19. Assessing risk
WHAT TO VALIDATE?
23. Developing the scope
24. Other consideration
25. Critical vs non-critical
26. Services and utilities
27. Computerized systems
28. Selecting process steps
29. Cleaning validation
30. Cleaning validation II
31. Laboratory test methods
32. What not to validate?
STAGES OF VALIDATION
36. V Model
37. The URS document
38. FAT and SAT
40. IQ Phase
41. OQ Phase
42. PQ Phase
43. Process validation
44. Validation & SOPs
45. Review of sequences
49. Validation Master plans
50. Protocols and reports
51. Document linkage
52. Documentation flowchart
53. Managing deviations
58. Types of changes
Define some important validation terms.
Describe the development of validation and regulatory control.
State the reasons for validation.
Describe the difference between critical and non-critical equipment, in terms of validation activities.
Describe the roles of a validation team.
List the scope of validation.
Describe the V model approach to validation.
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
- 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
- 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 may 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.