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cGMP: Documentation and Record Keeping (GMP05)

Certification Training
 
Rated 4.18/5
11 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 Manufacturing Practice (cGMP).
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

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

Biopharma Institute LogoTraining Program: cGMP: Documentation and Record Keeping
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 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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate cGMPs 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.

Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate cGMPs 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:


Introduction
- Objectives
- Reviews and assessment

Requirements
- What do you think?
- What do the GMP rules state?
- Regulatory requirements
- GMP compliance
- Documentation and records
- Document features
- Document control
- Select true or false for each statement
- What is required as part of GMP batch documentation? Select all that apply.

GMP documentation
- What do you think?
- What do the GMP rules state?
- Types of documentation
- Specifications
- Inward goods
- Manufacturing formula, instructions and batch records
- Other production documentation
- Quality control (QC)
- Fill in the blanks
- How must batch records be completed?

Record keeping
- What do you think?
- What do the GMP rules state?
- Importance of record keeping
- Completing records
- Which correction is correct?
- Select true or false for each statement

Case study
- What do you think?
- What do the GMP rules state?
- Introduction
- Identify some documentation issues
- Tell the QA Director what you think

Conclusion
- Summary

COURSE OBJECTIVES:


This module looks at the role of GMP documentation in providing a history of manufacturing from supplier to customer, including the requirements of master instructions, Standard Operating Procedures (SOPs), batch records, quality control records and how to complete GMP records.


- Recognise the importance of procedures
- Recognise the importance of record keeping
- Identify the possible consequences of not completing and certifying GMP documents
- Identify how to complete batch records and associated supporting documents

The cGMP: Documentation and Record Keeping Course is Included in the Following Professional Certification Programs:


Current Good Manufacturing Practice (cGMP) Professional Certification Program: The Current Good Manufacturing Practice (cGMP) Professional Certification Program provides a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for ph ... 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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