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Home » 21 CFR Part 211 Subpart J - Records and Reports

21 CFR Part 211 Subpart J - Records and Reports (ELM-210)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: 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: 21 CFR Part 211 Subpart J - Records and Reports
Training Provided By: Biopharma Institute

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

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThis course focuses on providing an understanding of the U.S. Food and Drug Administration's current Good Manufacturing Practices (cGMP) regulations on Records and Reports for drug manufacturing, processing, packing, or holding. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. A link to these regulations on the FDA's website is available in the Resources tab of this course. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.
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.

21 CFR Part 211 Subpart J - Records and Reports course is included in the following Professional Certification Programs:

21 CFR Part 211: Good Manufacturing Practice Professional Certification Program: The 21 CFR PART 211: Good Manufacturing Practice Professional Certification Program covers the essentials of current good manufacturing practice (cGMP) for finished pharmaceuticals. There are six areas of train ... Learn more


Who Should Take This Course?
Learning Objectives

General Requirements (Sect. 211.180)
Required Length of Time to Retain Records (a)(b)
Availability of Records and Reports (c)(d)
Written Records and Procedures for Annual Evaluation (e)(1)(2)
Notification of Responsible Parties (f)

Equipment Cleaning and Use Log (Sect. 211.182)
Equipment Cleaning and Use Log (Sect. 211.182)

Component, Drug Product Container, Closure, and Labeling Records (Sect. 211.184)
Component, Drug Product Container, Closure, and Labeling Records (Sect. 211.184)(a)(b)(c)(d)(e)

Master Production and Control Records (Sect. 211.186)(a)
Master Production and Control Records Requirements (b)(1-9)

Batch Production and Control Records (Sect. 211.188)(a)(b)(1-13)
Batch Production and Control Records (Sect. 211.188)(a)(b)(1-13)

Production Record Review (Sect. 211.192)
Production Record Review (Sect. 211.192)

Laboratory Records (Sect. 211.194)(a)(1-8)
Laboratory Records: Additional Requirements (b)(c)(d)(e)

Distribution Records (Sect. 211.196)
Distribution Records (Sect. 211.196)

Complaint Files (Sect. 211.198)
Written Procedures (a)
Complaint File Creation and Maintenance (b)
Written Record (1)(2)(3)

Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of Good Manufacturing Practices (cGMP).

Online Training: The Benefits of Remote Learning & 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 training reimbursement policy.
  • 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.

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