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cGMPs for Dietary Supplements (21 CFR Part 111)

cGMPs for Dietary Supplements (21 CFR Part 111) Certification Training


Program/Course ID:GMPDS
Enrollment Period:12 months.
Average Learning Time:~60 minutes.
Additional Resources:Supplemental materials/activities.
Credit Hours:1 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
Special New Year 25% Discount:Use this discount code: 2024NEWYEAR.
Discounted Price:
   $71.25 USD  
  Price: $95.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

Training Program: cGMPs for Dietary Supplements (21 CFR Part 111)
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
Biopharma Institute ReviewscGMP stands for current Good Manufacturing Practices. In the USA, for Dietary Supplements, these are prescribed by the Code of Federal regulations, 21 CFR Part 111. This training focuses on providing a comprehensive understanding of Current Good Manufacturing Practices (FDA 21 CFR Part 111) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

Some of the key points this course will explain are:
  • Dietary supplements are designed to complement one's diet and come in various forms like pills, capsules, gummies, liquids, and powders, and can resemble conventional foods like teas or bars.
  • The Dietary Supplement Health and Education Act (DSHEA) in 1994 regulates dietary supplement labeling, marketing, and safety, enabling broad usage while promoting proper usage guidelines.
  • Good Manufacturing Practices 21 CFR Part 111 lays down General Provisions, requirements for Personnel, Physical Plant and Grounds, Equipment and Utensils, Requirement to Establish a Production and Process Control System, Production and Process Control System: Requirements for Quality Control, Requirements for Components, Packaging, and Labels and Product That You Receive for Packaging or Labeling as a Dietary Supplement, Master Manufacturing Record, Batch Production Record, Laboratory Operations, Requirements for Manufacturing Operations, Packaging, and Labeling Operations, Holding and Distributing, Returned Dietary Supplements, Product Complaints and Records and Record keeping.
  • Insufficient Document Control, Batch Record Confusion, Reliance on Paper Documents, Real-Time Log Updates, and Delayed Approvals and Signatures can challenge GMP manufacturing of dietary supplements.
  • Warning letters are issued to companies by the FDA for unlawfully marketing dietary supplements as drugs to treat diseases, violating regulations. Products can also be recalled in case they are found to be non-compliant with FDA rules and regulations.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


Outline:


  • What is a dietary supplement
  • FDA and Dietary Supplement Health and Education Act of 1994 (DSHEA)
  • 21 CFR part 111: Subpart A - General Provisions
  • Subpart B - Personnel; Subpart C - Physical Plant and Grounds
  • Subpart D - Equipment and Utensils
  • Subpart E - Requirement to Establish a Production and Process Control System
  • Subpart F - Production and Process Control System: Requirements for Quality Control
  • Subpart G - Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
  • Subpart H - Production and Process Control System: Requirements for the Master Manufacturing Record; Subpart I - Production and Process Control System: Requirements for the Batch Production
  • Subpart J - Production and Process Control System: Requirements for Laboratory Operations
  • Subpart K Production and Process Control System: Requirements for Manufacturing Operations
  • Subpart L - Production and Process Control System: Requirements for Packaging and Labeling Operations; Subpart M - Holding and Distributing
  • Subpart N - Returned Dietary Supplements
  • and Subpart O - Product Complaints
  • Subpart P - Records and Record keeping
  • Challenges in GMP manufacturing of dietary supplements
  • Introduction to several cases studies where dietary supplement manufacturers have been issued warning letters by the FDA.
  • Conclusion
  • Final Assessment

Objectives:


Training Objectives:

This training focuses on providing a comprehensive understanding of Current Good Manufacturing Practices (FDA 21 CFR Part 111) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

By the end of this section, student will be able to:
  • Explain what Dietary Supplements are
  • Know the Regulations - FDA and Dietary Supplement Health and Education Act of 1994 (DSHEA)
  • Understand Good Manufacturing Practices 21 CFR Part 111
  • Describe the Challenges in GMP manufacturing of dietary supplements
  • Discuss case studies related to Warning letters on Non-Compliances and Recalls

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.


Have Questions? Contact Us:


Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.