Student Login |


Thursday, December 12, 2019
Home » GLP: QC in a Regulated Laboratory

GLP: QC in a Regulated Laboratory (GLP02)

Certification Training
 
Rated 4.11/5
9 reviews
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

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

Availability: Immediately available 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 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.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


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):


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 lab practice concepts and requirements in compliance w ... Learn more

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.

All Courses in the Good Laboratory Practices Catalog:


GLP: Introduction to QC: This online course introduces students to the basic requirements and concepts of Good Quality Control Laboratory Practices. It will review the standards used in the industry and specify QC requirements and defi ... Learn more

GLP: QC in a Regulated Laboratory: 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 w ... Learn more

GLP: Basic Statistics for QC Laboratories: This online course covers a number of practical and essential statistical techniques that are needed for the analyst working in a laboratory setting. Students will learn how and when to apply techniques to data ... Learn more

GLP: Sampling Plans: This online course discusses the unique problems found in pharmaceutical production, whether inactive or active chemical materials, unprinted or printed packaging materials, process water, in-process materials, ... Learn more

GLP: Stability Programs: This online course introduces the student to the requirements for stability programs, how they are reviewed, and their purpose. Also presented will be the basic requirements for scheduling tests. The course cov ... Learn more

GLP: Microbiology and QC: This online course provides an introduction to the basic requirements and concepts of quality control for microbiological testing laboratories operating under good laboratory practice (GLP) guidelines. The cour ... Learn more

GLP: Microbiology Laboratory Techniques: This online course describes a number of fundamental procedures and techniques that are used regularly in laboratories dealing in microbiology. The course covers topics such as biohazard cabinets and laminar fl ... Learn more

GLP Quality Control: Analytical Method Validation: 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 ... Learn more

GLP Quality Control: IQ/OQ and Calibration of Lab Equipment: This course is to be taken online, and covers the requirements for the qualification of laboratory instruments, including Performance Qualification (PQ), Operational Qualification (OQ), and Installation Qualifi ... Learn more

Online Training: The Benefits of eLearning

  • 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
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could 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.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):