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GMP: Documentation and Record Keeping (GMP05)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $199.00

dinaris.org LogoTraining Program: GMP: Documentation and Record Keeping
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This training program provides a comprehensive overview of current good manufacturing practices, with an emphasis on the role of proper documentation, and how it is used to provide a history of the manufacturing process, from supplier to customer. The course trains on how to develops logs, quality control records, batch processing records, and the requirements of standard operating procedures (SOPs). The course curriculum covers the following sections: quality alerts, the need for documentation, GMP documentation, and proper record-keeping. The training includes a case study to clarify the subject materials, and illustrate in a real-life scenario. Once all course requirements have been satisfied, you will immediately receive a Certificate of Completion via PDF.

Benefits of Getting Certified at dinaris.org

With a state-of-the-art e-learning system, dinaris.org makes online learning easier and effective. The Institute provides various educational implements to assist our students in learning the essentials. Whether your organization needs to run a massive training program for a large number of new employees, or a small scale course as a refresher, the Institute provides high-quality resources and exceptional industry knowledge with which to deliver a high quality training to you, your employees, and/or your colleagues.

dinaris.org is a top-of-the-line training institute for professionals with careers in industries such as healthcare, pharmaceuticals, clinical research, and biotechnology. We have assisted thousands of businesses since 1997, helping them with their employee training. A large spectrum of industries recognizes our certifications and our training solutions can be customized to the needs of any organization.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at 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.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The GMP: Documentation and Record Keeping Course is Found in the Following Professional Certification Program(s):


Good Manufacturing Practice (GMP) Professional Certification Program: The Good Manufacturing Practice (GMP) Professional Certification Program is a comprehensive overview on the best practices regarding control and management of manufacturing and quality control testing for pharm … Learn more

COURSE OUTLINE:


QUALITY ALERT
1. Quality Alert
2. Quality Alert II
3. What you will learn
4. Outcomes
NEED FOR DOCUMENTATION
5. Need for documentation
6. Documentation systems
7. Documentation and records
8. Review I
9. Review II
GMP DOCUMENTATION
10. GMP documentation
11. Specification
12. Inward goods
13. Production
14. Packaging
15. Quality Control
16. Master formulas
RECORD KEEPING
17. Record keeping
18. Changes to records
19. Review
CASE STUDY
20. The FixitKWIK problem
21. Records department
22. Dispensary
23. Formulations
24. Packaging
25. Quality Control
26. Interpreting
27. What is your conclusion?
SUMMARY
28. Summary I
29. Summary II

COURSE OBJECTIVES:


State the GMP requirements for documentation.
Explain the implications of not completing and certifying GMP documents.
Complete batch records and associated supporting documents.

JOB POSTINGS:

4295 QC QA Quality jobs found.
Displaying jobs #1-4.

Quality Supervisor
Posted Date: 2017-06-21
Ultimate – United States, CA, Camarillo, 93010

Assistant Quality Manager
Posted Date: 2017-06-20
CSL Plasma – United States, FL, Miami, 33222

Director, Quality VA
Posted Date: 2017-06-19
Blood Systems – United States, VA, Richmond, 23214

Quality Engineer
Posted Date: 2017-06-20
Apex Life Sciences – United States, NC, Whitakers, 27891

See more QC QA Quality Jobs


For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.

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