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GLP: QC in a Regulated Laboratory (GLP02)

Certification Training
 
Rated 4.11/5
9 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
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

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GLP: QC in a Regulated Laboratory
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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 immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE 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

COURSE 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.

The GLP: QC in a Regulated Laboratory Course is Included in the Following Professional Certification Programs:


Good Laboratory Practice (GLP) Professional Certification Program: The Good Laboratory Practice (GLP) Professional Certification Program comprises a set of seven courses designed to provide a comprehensive overview of good laboratory practice concepts and requirements in compl ... Learn more

cGMP for Microbiology, Quality Control and Contamination Control Professional Certification Program: The cGMP for Microbiology, Quality Control and Contamination Control Professional Certification Program offers a comprehensive overview of current good manufacturing practice (GMP) and Good (Quality Control) La ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

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.

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