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Thursday, September 23, 2021
Home » 21 CFR Part 211: Good Manufacturing Practice Professional Certification Program

21 CFR Part 211: Good Manufacturing Practice Professional Certification Program

Certification TrainingProgram/Course ID: GMPP11
Enrollment Period: 6 months.
Allocated Learning Time: ~14 - 20 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: 9 courses included (see below).
Digital Badge: Issued upon completion.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $1495.00

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

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Description:

To achieve a strong understanding of the different subparts of FDA 21 CRF Part 211, we recommend the 21 CFR Part 211: Good Manufacturing Practice Professional Certification Program (GMPP11). This program is developed to train employees involved in a broad range of responsibilities within a GMP compliant pharmaceutical manufacturing organization.

The 21 CFR PART 211: Good Manufacturing Practice Professional Certification Program provides a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for pharmaceutical product. There are several areas of focus: Building and Facilities, Control of Components, Drug Product Containers and Closures, Holding and Distribution, Production and Process Controls, Packaging and Labeling Control, Records and Reports, Organization and Personnel, Equipment, and Returned and Salvaged Drug Products.

Students earning this certification will have a strong understanding of these FDA codes, industry regulations, and standards. They will understand what is required to perform within the federal regulations and what is necessary to maintain compliance. Most importantly, students taking this program will have gained the knowledge and skills to successfully contribute within a GMP-compliant drug manufacturing environment.


21 CFR Part 211: Good Manufacturing Practice Professional Certification Program Includes These Courses:



 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart B - Organization and Personnel
Course ID: ELM-211
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart C - Building and Facilities
Course ID: ELM-205
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart D - Equipment
Course ID: ELM-212
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart E - Control of Components, Drug Product Containers and Closures
Course ID: ELM-206
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart F - Production and Process Controls
Course ID: ELM-208
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart G - Packaging and Labeling Control
Course ID: ELM-209
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart H - Holding and Distribution
Course ID: ELM-207
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart J - Records and Reports
Course ID: ELM-210
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart K - Returned and Salvaged Drug Products
Course ID: ELM-213
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Additional Details:

Certification Requirements: Students must view the entire program and successfully pass online, multiple-choice final assessments for each course within a 180 day/6-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Program enrollees can attempt the final assessments any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique certification ID code. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to validate the training achieved. Digital badges can be displayed on social networking sites, such as LinkedIn.

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.


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.


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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