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: Good Laboratory Practices.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $195.00
Training Program: GLP Quality Control: Analytical Method Validation
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
A fundamental QC requirement, both for GMP inspection of laboratories and product registration, is the analytical test method validation. Worldwide GMP auditing trends are currently focusing on Good Laboratory Practices and analytical method validation in particular.
This course is designed to provide students with procedures and techniques for the control, analysis, and validation of analytical test methods. The program covers such topics as performance parameter definitions, their acceptance criteria, and how to set up for linearity studies, precision, cost-efficient accuracy, etc. Also presented are industry requirements for documenting method validations (FDA, TGA, and ICH), as well as techniques and tips for method transfer. Once all course requirements have been satisfied, students will have immediate access to a certificate of completion in PDF format.
Benefits of Getting Certified at BioPharma Institute
Through the years, the BioPharma Institute has compiled a comprehensive offering of courses which can be taken online, books, recorded seminars, live seminars, and other training implements used to teach the various aspects of particular job functions and applications found within the pharmaceutical, biotechnology, and healthcare industries. We have proudly provided solutions and online training to companies and individuals working in thousands of US and overseas corporations.
With expertise in managing large training projects, our Institute strives to give professionals the assistance they need with uncovering fresh discoveries and furthering their understanding of the industry and the peripheral technologies within.
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 GLP Quality Control: Analytical Method Validation course is found in the following professional certification program(s):
2. Analytical method users
3. Regulatory standards
4. ICH standards
8. Basic validation philosophy
10. Analytic methods
11. Performance parameters
12. Protocol structure
METHOD PERFORMANCE PARAMETERS
14. Performance parameters
15. Precision I
16. Precision II
17. Accuracy I
18. Accuracy II
19. Method capability
20. Method specificity
21. Linearity and Range
22. Sensitivity, LOD and LOQ I
23. Sensitivity, LOD and LOQ II
24. Sensitivity, LOD and LOQ III
27. Method transfer verification
STABILITY INDICATING ASSAYS
COMPENDIAL METHOD VALIDATION
32. Pharmacopoeial methods
List the key method performance parameters used in validation.
Describe and calculate precision and accuracy.
Describe and calculate selectivity and sensitivity.
Describe and calculate linearity and range.
Describe and calculate robustness and system suitability.
State the differences between validation and verification of methods.
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.