NSF Training Courses
Virtual Training April 21 - May 2, 2023
SupplySide East has again partnered with NSF 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.
Dietary Supplement Label Compliance
It is up to dietary supplement manufacturers to ensure their supplement labels are compliant before they go to market, however the regulations can be confusing and difficult to interpret. Label noncompliance can cause your product to be considered misbranded and subject to Food & Drug Administration regulatory action. Learn about the regulations that govern dietary supplement labeling including what can be considered a dietary supplement.
- Label compliance/noncompliance
- Regulations that govern dietary supplement
- Supplement Facts formatting
- Ingredient lists
- Permitted claims, enforcement/litigation trends
- Adverse Event Reporting. The course is interactive
- The Regulatory Background and Enforcement · Mandatory Label Elements
- Voluntary Label Elements
- How to apply the FTC and FDA regulations
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Duration of Class:
6 Hours
Date of Class:
Thursday, April 21 | 11am-5pm ET
Trainer:
Nicole Leitz
21 CFR 111 Dietary Supplement GMP Overview
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
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.
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Duration of Class:
16 Hours
Date(s) of Class:
- Monday, April 24 | 11am-4pm ET
- Tuesday, April 25 | 11am-4pm ET
- Wednesday, April 26 | 11am-5pm ET
Trainer:
Norm Howe
Dietary Supplement Internal Auditing Training
This dietary supplement internal auditor course will help you understand the fundamentals of auditing and how to conduct an internal audit focused on cGMP and other FDA requirements. The training incorporates internal audit best practices, regulatory requirements and information on turning internal audit findings into useful information. Requirements for 21 CFR 111, supplier programs and FSMA are incorporated into the content.
Internal Audit Basics and Best Practices
Introduction to internal auditing
- Using checklists
- Conducting the audit
- Incorporating Regulatory and cGMP Requirements in Internal Auditing
21 CFR 111 and 21 CFR 117 for warehousing and distribution
- Supplier program requirements
- Records and procedures
Turning Audit Findings into Useful Information and Continuous Improvement
- Communicating audit reports
- Importance of a good CAPA system
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Duration of Class:
8 Hours
Date of Class:
- Wednesday, April 27 | 1pm-5pm ET
- Thursday, April 28 | 1pm-5pm ET
Trainer:
Shawn Ludlow
Root Cause Analysis (Investigative and Justification Writing)
Inthis training we will address topics covering Non-conformance Reporting (NCRs),CAPAs and Problem Reporting (PR) writing. We will review Root Cause Analysis writing,how to write clear investigations that flow, identify real root cause(s),implement effective corrective/preventative actions, justify, prove, and defenddecisions. You will learn how to writeclear and concise justification letters that support RCA and CFR to explain,prove, and defend your decisions.
Non-conformance Reporting (NCRs)
- Basic requirements of the CGMPs.
- Deviations & Unexpected Occurrences
- Timeliness of reporting and investigations
CAPAs and Problem Reporting (PR) writing: Thorough Root Cause Analysis writing
- Root Cause Analysis (RCA) Best Practices
- Failure Investigations for RCA
- Investigations of Lab Results
- Analyzing Batch Production Records for RCA
- Review of Logs, Forms, and other process
documentation for RCA? - How to recognize when you have found the root
cause(s) - What happens when you cannot determine a root cause?
- What reports must be written during the RCA process?
- Corrective Action &Preventive Action (CAPA)
- Sustainable and Effective CAPAs - How to write them
- Establishment of monitoring and measuring
- Verification of effectiveness? Are products oroutcomes improved?
- Did the actions address problem causes, instead ofjust symptoms?
- Communication to applicable parties fosteringcontinual improvement
Justifications
- How can I write justification decisions in a way acceptable to 21 CFR 111?
- What kind of scientific or other evidence is needed to support my case?
- How do I support my justifications with that scientific evidence and/or cases studies?
- Is a reduction of the root cause good enough?
- Playing "devil's advocate" with justifications decisions and defending justification decisions
- Analyzing risks of justification decisions
- Will the justifications need to be followed up on? How will that occur?
- Temporary v. Long Term justification decisions and the requirements of each
- Peer review of justifications
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Duration of Class:
8 Hours
Date of Class:
- Monday, May 1 | 1pm-5pm ET
- Tuesday, May 2 | 1pm-5pm ET
Trainer:
Vijay Bachus
