Involved in the manufacturing, packaging, labeling, holding, or quality control operations of dietary supplements?
The Federal regulations require personnel engaged in these functions to have the education, training, or experience to perform the assigned functions. It is essential to be trained in the dietary supplement current Good Manufacturing Practices (cGMPs) – 21 CFR 111. Further, that training must be documented.
Taught online in English or Spanish – $399 per learner, including Certificate of Completion
This course is ideal for anyone working in the dietary supplement industry involved in the following areas:
- Quality Assurance/Control
- Regulatory Affairs
- Laboratory technicians
- Warehouse and Distribution
- New hires
The Dietary Supplement cGMP Online Training Course from Dietary Supplement Experts is an excellent and simple solution for your company’s training needs. The course is designed to present the 21 CFR 111 requirements at an understandable and practical level. After completion, Certificates of Completion are issued to document training.
Invest in your team, save time and money, and meet your GMP training needs with Online Dietary Supplement GMP Training – Now Available in Spanish or English.
Online training can help increase your confidence that your operations are compliant with the regulations. Our online training course offers training that can be done at your convenience from your office or home, without the travel expenses of on-location courses.
What is Included:
- Choose English or Spanish language
- Certificate of Completion issued for training documentation
- Streaming training video more than one hour in length can be accessed from virtually any device
- Covers all 21 CFR 111 Subparts, plus Good Documentation Practices
- Presented in an easy to understand format
About the Instructor
Andy M. Swenson has been in the dietary supplement industry for the last 20 years and worked with some of the most prominent and quality-minded organizations in the business. He has a broad background which spans quality, product development and manufacturing. This provides a unique perspective when building quality systems or developing the next new product and enables him to meet departmental and customer needs while still maintaining 21 CFR 111 compliance. He has worked with virtually all the major dosage forms (capsules, tablets, powders, etc.) and product lines (herbals, vitamin/mineral, extracts, etc). In addition, Andy understands how to balance the regulatory risks with the financial realities of running a profitable business.
- Introduction – Meet your instructor, learn the agenda for the training course.
- Section 1 – GMP / Final Rule Overview
- Section 2 – Good Documentation Practices
- Section 3 – Subpart A (General Provisions)
- Section 4 – Subpart B (Personnel)
- Section 5 – Subpart C (Physical Plant and Grounds)
- Section 6 – Subpart D (Equipment and Utensils)
- Section 7 – Subpart E (Requirement to Establish a Production and Process Control System (PCS))
- Section 8 – Subpart F (PCS: Requirements for Quality Control)
- Section 9 – Subpart G (PCS: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement)
- Section 10 – Subpart H (PCS: Requirements for the Master Manufacturing Record)
- Section 11 – Subpart I (PCS: Requirements for the Batch Production Record)
- Section 12 – Subpart J (PCS: Requirements for Laboratory Operations)
- Section 13 – Subpart K (PCS: Requirements for Manufacturing Operations)
- Section 14 – Subpart L (PCS: Requirements for Packaging and Labeling Operations)
- Section 15 – Subpart M Holding and Distributing
- Section 16 – Subpart N Returned Dietary Supplements
- Section 17 – Subpart O Product Complaints
- Section 18 – Subpart P Records and Recordkeeping