GLP: QC in a Regulated Laboratory

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Program/Course ID: GLP02 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials/activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with validation QR barcode.

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2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: INTERNATIONAL COMPLIANCE STANDARDS 1. Introduction 2. Terminology 3. Compliance rules 4. Pharmacopoeias 5. cGMP references 6. Interpreting the rules 7. Review SPECIFICATION AND STANDARDS 8. Introduction 9. Specification 10. Reference standards 11. Preparing and standardizing 12. GLP labeling GOOD AUTOMATED LABORATORY PRACTICES 13. Introduction 14. Raw vs Derived data 15. CFR Part 11 requirements 16. Recording raw data 17. HPLC 18. Raw data storage 19. Storing electronic data 20. Review COMPLETION OF NOTEBOOKS AND RECORDS 21. Introduction 22. Notebooks and worksheets 23. Completing records 24. Checking calculations 25. Archiving rules for records 26. Supporting records 27. Review SAMPLE AND DATA INTEGRITY 28. Introduction 29. Sample lifecycle 30. Altering records 31. Example 32. Significant figures 33. Review MANAGING OOS EVENTS 34. Introduction 35. Out-of-specification 36. OOS origin 37. GLP rules regarding OOS 38. OOS handling 39. Resolving OOS events 40. Handling OOT events 41. Review CONCLUSION 42. Summary		Objectives: 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.

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Benefits of Training with Biopharma Institute

Immediate access to courses:	Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:	24/7 access to all course materials and assessments for 12 months.
Open enrollment:	No prior course prerequisites or work experience required.
Expertise:	Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:	Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:	Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:	Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:	Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:	Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:	Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:	A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:	Courses can be delivered directly to most corporate Learning Management Systems (LMS).
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Reimbursement:	Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:	Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
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Comments: For quotes or invoices please provide the course(s) and number of students.	GLP: QC in a Regulated Laboratory