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: QC in a Regulated Laboratory
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
This online course introduces students to the basic requirements and concepts of quality control in a regulated pharmaceutical laboratory. It discusses issues that laboratory auditors focus on. Also presented will be particular pharmaceutical regulatory requirements, including, but not limited to, current good automated laboratory practices, the handling of specific conditions, and requirements for investigation of specific conditions. There will be a review of the current guidelines published by the FDA and the TGA. 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
Whether your organization needs to run a large-scale training program for new employees or a small scale refresher course, BioPharma Institute has the resources and industry knowledge to deliver top-of-the-line training for you, your employees, and your colleagues. Our state-of-the-art e-learning system makes online learning seem easy while providing various educational implements to help students learn the essentials.
BioPharma Institute's certifications are recognized in many well-known industries, and our training program solutions can be customized to fit the needs of most organizations. For over two decades, we have aided thousands of businesses in the training of their employees. We are at the top of our game when it comes to online training for professionals working in the pharmaceutical, biotechnology, and healthcare industry.
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: QC in a Regulated Laboratory course is found in the following professional certification program(s):
INTERNATIONAL COMPLIANCE STANDARDS
3. Compliance rules
5. cGMP references
6. Interpreting the rules
SPECIFICATION AND STANDARDS
10. Reference standards
11. Preparing and standardizing
12. GLP labeling
GOOD AUTOMATED LABORATORY PRACTICES
14. Raw vs Derived data
15. CFR Part 11 requirements
16. Recording raw data
18. Raw data storage
19. Storing electronic data
COMPLETION OF NOTEBOOKS AND RECORDS
22. Notebooks and worksheets
23. Completing records
24. Checking calculations
25. Archiving rules for records
26. Supporting records
SAMPLE AND DATA INTEGRITY
29. Sample lifecycle
30. Altering records
32. Significant figures
MANAGING OOS EVENTS
36. OOS origin
37. GLP rules regarding OOS
38. OOS handling
39. Resolving OOS events
40. Handling OOT events
List, locate and interpret several G(QC)LP compliance standards.
Describe how to manage reference standards and standard reagents.
State key compliance rules for managing automated information.
Describe the GLP 'rules' for completing laboratory notebooks.
Describe the GLP 'rules' for reporting and altering laboratory data.
List the essential requirements for evaluating laboratory OOS conditions.
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.