Method of Training: Online / Self-paced eLearning.Credit Hours: 1 credits.
Duration: ~1 hour(s).
Self-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 $95.00
Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.Training Program: 21 CFR Part 211 Subpart B: Organization and Personnel
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
The organization and personnel (21 CFR Part 211, Subpart B) training course is one of the six courses that make up the 21 CFR PART 211 Employee Certification Program. As an employee working in a pharmaceutical manufacturing firm, you must know how the organization functions. In addition, the course covers the responsibilities of how a quality control unit should operate (i.e., knowing how to approve or reject components of the drug product manufacturing process). The final assessment features multiple-choice questions, and students can take the test an unlimited number of times to pass. You will earn your certificate upon course completion.
Benefits of Getting Certified at BioPharma Institute
BioPharma Institute has been providing online training solutions for thousands of corporations across the biotech, healthcare, and pharmaceutical industries. We make the process of training employees extremely easy. This is done using our effectively designed eLearning programs. The convenience our courses provide is second to none, and allows students to learn within a flexible schedule. Regardless of your organization size, you can rest assured that we cater to both small-scale and large-scale training projects.
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.
The 21 CFR Part 211 Subpart B: Organization and Personnel Course is Included in the Following Professional Certification Programs:
Full List of Programs in the GMP Employee Training Catalog:
|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|
|cGMP for Medical Devices Professional Certification Program: This program is essential for those to learn how to be compliant with the FDA's quality system regulations for current good manufacturing practices (cGMP), with emphasis on medical devices. This certification p ... Learn more|
|21 CFR Part 211: cGMP Regulations and Controls: The 21 CFR Part 211: cGMP Regulations and Controls training course is one of six training content sections covered under the 21 CFR Part 211 Employee Certification Program. When it comes to designing, manufactu ... Learn more|
|21 CFR Part 211 Subpart B: Organization and Personnel: The organization and personnel (21 CFR Part 211, Subpart B) training course is one of the six courses that make up the 21 CFR PART 211 Employee Certification Program. As an employee working in a pharmaceutical ... Learn more|
|21 CFR Part 211 Subpart C: Buildings and Facilities: This buildings and facilities course (21 CFR Part 211 Subpart C) is one of the courses covered in the 21 CFR PART 211 Employee Certification Program. Students will gain an in-depth understanding of the requirem ... Learn more|
|21 CFR Part 211 Subpart D: Equipment: The 21 CFR Part 211 Subpart D, Equipment Course discusses both the design and construction requirements for lubrication and coolants, documentation requirements, personnel training requirements, equipment ident ... Learn more|
|21 CFR Part 211 Subpart E: Materials: The 21 CFR Part 211 Subpart E: Materials Course is one part of the 21 CFR PART 211 Employee Certification Program. The course consists of topics that cover GMP requirements, such as supplier qualification, manu ... Learn more|
|21 CFR Part 211 Subpart F: Production and Process Controls: The 21 CFR Part 211 Subpart F: Production and Process Controls course reviews the requirements which need to be met to assure drug products have the purity, quality, strength, and identity they are represented ... Learn more|
|GMP: Contamination Control for Employees: The GMP: Contamination Control for Employees course covers topics such as potential sources of contamination and ways to prevent medical products from becoming contaminated. The course is also included in the E ... Learn more|
|GMP: Proper Documentation Practices: The GMP - Proper Documentation Practices course is one of the courses found in the Employee cGMP for Medical Devices Professional Certification Program. The course consists of various topics. The topics include ... Learn more|
|GMP: Root Cause Analysis: The GMP - Root Cause Analysis Course provides answers on how clinical, pharmaceutical, and laboratory professionals can investigate, identify, and resolve root cause of deviations in modern manufacturing practi ... Learn more|
|21 CFR Part 820: cGMP System Regulation: The 21 CFR Part 820: cGMP System Regulation course summarizes the essential elements of cGMP regulations governing the methods and facilities used for the servicing, installation, storage, labeling, packaging, ... Learn more|
|GMP: Surviving an FDA Inspection: This GMP - Surviving an FDA Inspection Program teaches participants how to behave during, how to plan for, and what to expect from an inspection. This program has demonstrations involving different response str ... Learn more|
|GMP: Understanding Validation: This GMP - Understanding Validation program provides a overview of good manufacturing practice, with a comprehensive emphasis to understanding validation. This course, which is based on a 2008 guidance document ... 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