cGMP: Documentation and Record Keeping (GMP05)
 | Duration: 2 hours, Online (the average time to complete the training program, including final assessments). Credits Hours: 2Self-paced Training: 24/7 access to course. Enrollment Period: 3 months. Catalog: Good Manufacturing Practices (GMP). Demonstration: Try one of our FREE courses. Certificate: View sample certificate. PRICE: USD $199.00 
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 Training Program: cGMP: Documentation and Record KeepingTraining Provided By: BioPharma Institute Website: https://www.biopharmainstitute.com 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 BioPharma Institute With a state-of-the-art e-learning system, BioPharma Institute 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. BioPharma Institute 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) 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 cGMP: Documentation and Record Keeping course is found in the following professional certification program(s):
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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 cGMP requirements for documentation. Explain the implications of not completing and certifying GMP documents. Complete batch records and associated supporting documents. | |
All Courses in the Good Manufacturing Practices Catalog:
 | cGMP: Documentation and Record Keeping, An Abridged Course: The GMP: Documentation and Record Keeping, an Abridged Course, is a shortened course used for demonstration purposes only. The full length course poses the questions: Can you withstand an FDA audit? How familia ... Learn more |
 | cGMP: An Introduction to Good Manufacturing Practices: This GMP course includes an introduction to current good manufacturing practices (cGMPs), information on maintaining product quality, the scope of GMP rules, a section on cleaning and sanitation, a look into pr ... Learn more |
 | cGMP: Warehouse: The GMP for the Warehouse training program provides an overview and discussion of the role current good manufacturing practices has in the warehouse; and offers an emphasis in receipts, issues, storage, and dis ... Learn more |
 | cGMP: Microbiology in the Workplace: The GMP: Microbiology In the Workplace training program offers a comprehensive overview of microbiology in the workplace, as it relates to current good manufacturing practices. The syllabus of this course inclu ... Learn more |
 | cGMP: Cleaning and Sanitation: This Good Manufacturing Practice (GMP) in Cleaning and Sanitation training program offers a comprehensive overview and a solid introduction to cleaning and sanitation, as it relates to the regulator of quality ... Learn more |
| cGMP: Documentation and Record Keeping: 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 manufacturin ... Learn more |
 | cGMP: Contamination Control: This online training course offers a overview of good manufacturing practice with a comprehensive emphasis on contamination control. The program builds on microbiology in the workplace course, GMP03, and addres ... Learn more |
 | cGMP: Production Controls: This program offers an overview of good manufacturing practice, with a comprehensive emphasis on production controls. The program builds on GMP06, the contamination control course. The course will describe and ... Learn more |
 | cGMP: Packaging Controls: The good manufacturing practice in packaging controls program describes cGMP requirements for the control of packaging materials and operations. Students will explore the reasons that labeling problems still co ... Learn more |
 | cGMP: Quality Assurance and Quality Control: This course emphasizes quality assurance and quality control, with respect to good manufacturing practices. Participants explore GMPs as they apply to quality testing, management, manufacturing, and the control ... Learn more |
 | cGMP: Pharmaceutical CAPAs: This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The ... 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.
