Virtual Training August 30 - September 3, 2021
SupplySide East has partnered with NSF Health Sciences to offer you education courses to expand your industry knowledge on regulatory requirements and risk mitigation. Courses and payment take place within the NSF Health Sciences platform. | | |
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21 CFR 111 Dietary Supplement GMP Overview Monday, August 30 | 12-5pm ET Tuesday, August 31 | 12-5pm ET Wednesday, September 1 | 11am-5pm ET
Attend an extensive training course on 21 CFR 111, the current Good Manufacturing Practices (cGMPs) in manufacturing, and packaging, labeling, or holding operations for dietary supplements. This course is geared to those individuals involved in the dietary supplement industry including: | Manufacturing Management Packaging and Labeling Suppliers and Distributors Other Technical Professionals | | Quality Control Quality Assurance Laboratory Operations Auditing Regulatory Affairs and Compliance |
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These guidelines are intended to be applicable to dietary supplements as defined and covered by 21 CFR 111, but may also be applied to dietary ingredients and other components. The course provides an in-depth review of the regulation and provides case studies to review recent FDA Warning Letters initiated to Dietary Supplement companies for non-compliance with 21 CFR 111 GMPs. Cost of Class: $1,400.00 Dietary Supplement Claims Substantiation Thursday, September 2 | 11am-5pm ET The labeling and promotion of your dietary supplement products are the most visible ways that the Food & Drug Administration and the Federal Trade Commission can track your compliance with federal regulations. A perfect complement to “Introduction to Product Labeling for Dietary Supplement”, this course will go over in detail each type of permitted claim that is available to you and the criteria for making each one. We will cover FDA and FTC standards for substantiation, how to build the substantiation for each claim that the FDA and FTC requires you to hold to ensure your claims are accurate and not misleading, and how you can avoid making implied claims which could lead to regulatory enforcement. Participants will learn how public knowledge of FTC and FDA enforcement actions affect business performance, enforcement/litigation trends and other responsibilities of dietary supplement manufacturers such as structure/function claim notification. Cost of Class: $800.00 Vendor Qualification and Audit Training Thursday, September 2 | 11am-3pm ET Friday, September 3 | 11am-3pm ET
Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. But FDA does not provide much guidance on how to qualify vendors. This class is designed for to give people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers. Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. The auditing skills and techniques learned in this course are independent of the type of auditing or the standard being audited. At the end of this course attendees will have an understanding of: | The regulations that apply to Vendor Qualification 21 CFR 111 The impact of FSMA on Supplier Qualification Risk assessment and risk management Supplier monitoring activities | | Onsite Audit Strategies & Requirements Managing the audit process effectively-before, during after The consequences of noncompliance |
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Cost of Class: $800.00 SOP and Record Keeping Friday, September 3 | 11am-5pm ET
The Dietary Supplement GMPs (21 CFR 111) are performance-based regulations. The regulations tell you what you need to accomplish, but they tell you very little about how to go about getting there. The good news is that you have a great deal of flexibility in HOW to accomplish the specified requirements. The bad news is that YOU have to write SOPs that detail how you will accomplish those requirements. This course will help you to construct your SOP and recordkeeping system. It will walk you through the process of creating SOPs and records. Participants will learn which SOPs are required in order to have a complete quality system. Cost of Class: $800.00 supplysideeast.com | 