SupplySide West

GMP Training


Monday, October 6 & Tuesday, October 7

8am-5pm
(Both days)

21 CFR 111 Dietary Supplement GMP Overview

This extensive two-day training course covers 21 CFR 111, the current good manufacturing practices (cGMPs) in manufacturing, packaging, labeling or holding operations for dietary supplements. This course is geared to individuals involved in the dietary supplement industry including those from the following areas: manufacturing, management quality control/assurance, laboratory operations, labeling, auditing, suppliers and distributors, and regulatory affairs. These guidelines are intended to apply to dietary supplements as defined and covered by the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 111 (Current Good Manufacturing Practices in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) also known as 21 CFR Part 111.

This is Part I of a 2-day course.
Monday, October 6 – 8am-5pm
Tuesday, October 7 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $1,200
Pre-Registration Price August 8-October 3 $1,300
Onsite Price October 4-Onsite $1,400
Monday, October 6 or Tuesday, October 7

8am-5pm
(Monday)

or

8am-5pm
(Tuesday)

The Top 10 Ways to Get a Warning Letter – for Dietary Supplement Manufacturers

NSF has gathered data from recent FDA inspections, from ex-FDA inspectors and from its own auditors to bring you the latest trends in dietary supplement inspections. As in previous years, dietary ingredient identification is hot again! But you'll be amazed at which issues have dropped off the list and which ones have clawed their way to the top.

This is a 1-day course that's being repeated on Tuesday.
Monday, October 6 – 8am-5pm
or
Tuesday, October 7 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 3 $900
Onsite Price October 4-Onsite $1,000
Monday, October 6

8am-5pm

SOPs and Record Keeping for Compliance to 21 CFR 111

According to the FDA, if it wasn't written down, it didn't happen. Record keeping and documentation are a key component for compliance to 21 CFR 111. Through the cGMP regulations that were enacted in June of 2007, the FDA has established industry-wide standards to ensure identity, purity, strength and composition of manufactured dietary supplements. The regulations are specific with respect to the procedures that must be in place, and the records that must be maintained in support of those procedures; however, they are somewhat vague and don't offer clear guidelines for achieving compliance. In addition, companies are left to determine the level of compliance they need to put in place, and the frequencies for tasks that must be performed in order to continue to comply with the regulations. This course walks through the regulation, providing guidance on the necessary documentation and tools for compliance.

1 Day Session:
Monday, October 6 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 3 $900
Onsite Price October 4-Onsite $1,000
Tuesday, October 7

8am-5pm

FDA Inspection Readiness Training

This course provides attendees the tools necessary to successfully manage an inspection by the FDA. The implementation deadlines for 21 CFR 111 have passed, and the FDA is actively auditing all sizes of companies involved in the manufacturing, packaging, labeling, holding and distributing of dietary supplements. Establishing a good reputation with the FDA takes a long time, and only one negative inspection can seriously damage that reputation. Ensuring the most positive outcome for your cGMP inspection requires careful planning and preparation well before it occurs, successful management of many issues during the inspection itself, and thorough follow-up after the inspection. This course provides real-world examples and utilizes classroom exercises that will take each participant through the different phases of an FDA audit, demonstrating tools and techniques for successfully managing an inspection.

1 Day Session:
Tuesday, October 7 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 3 $900
Onsite Price October 4-Onsite $1,000
Monday, October 6 or Tuesday, October 7

8am-5pm
(Monday)

or

8am-5pm
(Tuesday)

Botanical Testing – A Hands-On and Analytical Test Methods

This course is designed for any quality assurance personnel working to meet FDA compliance for botanical identification (ID), and will analyze botanical unknowns through classical botany and sensory testing systems for botanical ID. This course may also support in-house testing for botanical ID by reviewing the important aspects of quality assurance in testing and test development of botanical ingredients and its relation to the natural products industry and alternative medicine practices. Proposed guidelines for herbal ID testing will be reviewed as it relates to GMPs, cGMP, and all issues regarding quality testing. Participants will be taught through lecture and lab participation how to analytically test and record these subjective systems.

This is a 1-day course that's being repeated on Tuesday.
Monday, October 6 – 8am-5pm
or
Tuesday, October 7 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 3 $900
Onsite Price October 4-Onsite $1,000
Tuesday, October 7

8am-Noon

Batch Production Records – Do's and Don'ts

Formal Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) have long been required in the pharmaceutical world, but the new Good Manufacturing Practices for dietary supplements (21 CFR 111) bring these requirements to this industry as well. Deficiencies in MMRs and BPRs are among the most frequently cited during audits or inspections, including those from FDA. This course will examine common issues and pitfalls with MMRs and BPRs and provide specific guidance on how to avoid these problems. Best practices will also be highlighted to enable your batch records not only withstand audits and inspections, but also streamline and improve your internal operations.

½ - Day Session:
Tuesday, October 7 – 8am-Noon

Cost:
Early Bird Price Now-August 7 $500
Pre-Registration Price August 8-October 3 $600
Onsite Price October 4-Onsite $700
Monday, October 6

1-4pm

NDIs and GRAS Notification – A How To

This introductory course will cover how to determine whether you need to submit a New Dietary Ingredient (NDI) Notification and considerations in determining if the use of an ingredient is Generally Recognized as Safe (GRAS). The course is directed toward dietary supplement and food ingredient manufacturers and suppliers who are interested in understanding the basic requirements so they can better communicate with regulators and specialists. Attendees will learn the similarities and differences between GRAS and NDI notifications, and pitfalls to avoid. Topics to be addressed during this three-hour course include:

  • How to describe and characterize your ingredient
  • Documenting history of use
  • How to contract good laboratory practice (GLP) toxicology studies
  • Compiling the necessary documentation
  • Establishing safety under the conditions of intended use
  • When and how to engage experts and the role of the expert panel

1 Day Session:
Monday, October 6 – 1-4pm

Cost:
Early Bird Price Now-August 7 $400
Pre-Registration Price August 8-October 3 $500
Onsite Price October 4-Onsite $600

 

  • #SSWExpo