Official GMP Training Program at SupplySide
Presented by
The official GMP training workshops at SupplySide are designed to provide real-world, hands on training and tools to help anyone involved in dietary supplement GMP compliance. Far from a lecture or seminar, these interactive training courses delve into the actual processes and procedures you must understand and implement to ensure GMP compliance.
FDA has been conducting GMP inspections, and the results of these initial inspections form the foundation of the content for these three unique training courses.
These courses are geared to those individuals involved in the dietary supplement industry, including those from the following areas:
- Manufacturing
- Labeling
- Management
- Auditing
- Quality Control/Assurance
- Suppliers and Distributors
- Laboratory Operations
- Regulatory Affairs
Training Fees, Course Inclusions and Discounts
Choose between three training courses, one 100 level course and two 200 level courses. Each course includes training workbooks and materials, and lunch on October 10. Register 4 or more people from the same company and receive an additional 10% discount.
100 Level Course: 21 CFR 111 – Dietary Supplement GMP Overview
These guidelines are intended to be applicable to dietary supplements as defined and covered by the United States 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, but may also be applied to dietary ingredients and other components. This course provides an in-depth review of the guidelines and provides case-studies involving the review of recent warning letters initiated to dietary supplement companies for non-compliance to 21 CFR 111 GMPs.
More Info
These guidelines are intended to be applicable to dietary supplements as defined and covered by the United States 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, but may also be applied to dietary ingredients and other components. This course provides an in-depth review of the guidelines and provides case-studies involving the review of recent warning letters initiated to dietary supplement companies for non-compliance to 21 CFR 111 GMPs.
Who should attend?
Quality and technical professionals including QA/QC, manufacturing, engineering, regulatory affairs and compliance, laboratory and other key personnel.
Course trainer will cover:
- Comprehensive review of the regulations providing a thorough understanding of each subpart relevant to a company's operations
- Interpretation of each subpart, providing an understanding of how to apply the principles to an employee or company's specific situation
- Examples of real-world scenarios highlighting areas in which dietary supplement companies' operations were compliant vs. non-compliant with the regulations
- Thorough review of some of the recent FDA warning letters submitted to dietary supplement companies and evaluation of their non-conformances with the regulations
- Best practices and how to address challenging quality issues
- A comprehensive introduction to the GMPs for new personnel or fulfills the need as refresher training to those in QA/QC, manufacturing, production, or R&D seeking to meet a GMP training requirement
Less Info
'100 Level Course: 21 CFR 111 – Dietary Supplement GMP Overview’ registration: $1,095
200 Level Course: GMP Vendor Qualification & Auditor Training
Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements must “qualify” each of their vendors but does not provide guidance on how a company is to perform this qualification. Supplier qualification principles also apply to subcontracted services affecting cGMP (manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.). Any supplier qualification program must include two critical components:
- Clearly defined specifications / requirements for all of these goods or services being purchased, and;
- Objective evidence to show that your requirements are being consistently fulfilled.
This course will offer guidance on how to achieve both of the above critical requirements in ways that will enable compliance with cGMP and make the most efficient use of your resources.
More Info
Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements must "qualify" each of their vendors but does not provide guidance on how a company is to perform this qualification. Supplier qualification principles also apply to subcontracted services affecting cGMP (manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.). Any supplier qualification program must include two critical components:
- Clearly defined specifications / requirements for all of these goods or services being purchased, and;
- Objective evidence to show that your requirements are being consistently fulfilled.
This course will offer guidance on how to achieve both of the above critical requirements in ways that will enable compliance with cGMP and make the most efficient use of your resources.
A working group was established several years ago to develop a "guideline" for industry that would provide them with tools for implementing or updating a vendor qualification program in their operations. The guideline also shares industries' current best practices while recognizing some of the challenges in qualifying various suppliers. This training program will dissect the industry guidelines while also providing a thorough understanding of how the concepts outlined can be tailored for various companies' operations through qualifying CofA's, conducting identity and other appropriate testing, auditing of suppliers, etc.
Since the evaluation of suppliers of all types often involves auditing, this course will also incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. These auditing skills and techniques are independent of the type of auditing or the standard being audited, so they will be useful to conducting internal audits as well as performing audits of suppliers.
Who should attend?
This training course would be valuable to QA/QC, regulatory and compliance, laboratory, and other key personnel who are in charge of or a part of implementing a new or modifying an existing vendor qualification program into their dietary supplement companies' operations. The course would also be useful for purchasing and production managers, who may be involved in the vendor determination process and could benefit from understanding some of the important elements in qualifying a supplier.
Course Outline:
- What is required under the GMP regulation
- The basics of the GMP and establishing identity and vendor qualification
- Contracts and vendor agreements
- The critical role of setting specifications
- Testing for identity and other appropriate chemical, physical, and microbiological properties
- What constitutes a scientifically valid method and examples of methods that are "fit for purpose"
- The importance of specifications
- OOS procedures and consequences
- Qualifying a 3rd Party Laboratory to Conduct Testing
- Specifications and identity testing using 3rd party vendors
- How to determine the expertise of a 3rd party laboratory
- Why specific expertise is important
- Appropriate accreditation & certification
- Supplier/Vendor Qualification
- Vendor qualification & re-qualification
- OOS (Out-of-Specifications) Investigations and Resolutions
- SIDI Working Group Efforts
- Auditor Training
- Important personal characteristics and interpersonal skills for successful auditing
- Tools and techniques to make your auditing more effective
- Aligning audit activities with the right goals and objectives
- Process and systems focus in auditing
- Managing the audit process effectively – before, during, and after
Less Info
‘200 Level Course: GMP Vendor Qualification & Auditor Training’ registration: $1,095
200 Level Course: Stability Program Development
Although federal regulations do not require the use of dietary supplement product expiration dates, according to the Federal Register GMP Preamble, June 25, 2007, Volume 72 Page 34,856, “when such dates are assigned they should be supported by data that qualifies the stability of the product.” A working group was established in 2009 to develop a “guideline” for industry that would provide them with tools for conducting stability studies and implementing stability program in their operations. The guideline is intended to provide practical guidance on what should be considered when developing voluntary written shelf-life study protocols to establish or confirm expiration dating of dietary supplements.
More Info
Although federal regulations do not require the use of dietary supplement product expiration dates, according to the Federal Register GMP Preamble, June 25, 2007, Volume 72 Page 34,856, “when such dates are assigned they should be supported by data that qualifies the stability of the product.” A working group was established in 2009 to develop a “guideline” for industry that would provide them with tools for conducting stability studies and implementing stability program in their operations. The guideline is intended to provide practical guidance on what should be considered when developing voluntary written shelf-life study protocols to establish or confirm expiration dating of dietary supplements.
Who should attend?
The training is designed for QA/QC managers, R&D managers and personnel, product developers, analytical method developers and laboratory personnel, quality system auditors and staff, and regulatory personnel.
What you will learn:
This training program will dissect the industry guideline while also providing real-world scenarios and exercises in designing the appropriate specifications for a stability study. Some other highlights include:
- How to identify issues related to the physical, chemical and microbiological characteristics of the components under long term storage
- Understand the impact that manufacturing, packaging, labeling, and holding/warehouse processes may have on the stability profile of products
- How to ensure that the finished products have initial-release specifications that help assure compliance with long-term stability specifications and suitable overages
- How to determine the stability of the finished product in the container-closure system that will be marketed
- Review of any historical data related to the formulation or the container-closure system that may be relevant to the stability of the product
- How to review applicable label claims related to stability aspects of the finished product to ensure that stability studies are designed to support these claims, as necessary
- Understand the distribution (including transportation) and storage conditions that the dietary supplement will be subjected to over its shelf life and factor these conditions into the stability study as necessary
- How to consider the suitability of accelerated stability studies on new product forms, as some components may react differently at increased temperatures or humidity levels than at ambient conditions
- How to consider the potential for the formation of degradation products and set corresponding stability indicating specifications as necessary
Course Outline:
This training program will dissect the industry guideline while also providing real-world scenarios and exercises in designing the appropriate specifications for a stability study. Some other highlights include:
- General principles of shelf-Life studies
- Selection of batches
- Bracketing or matrixing
- Types of testing
- Container-closure systems
- Types of studies/testing to support shelf-life (expiration) dating claims (i.e. accelerated studies, long-terms studies, retain sample testing, open product testing, excursion testing, etc.)
- Shelf-life study protocol development
- Shelf-life evaluation/study report
- Statements/labeling
- Process or product changes
- Marketed rroduct reserve samples and written records
Less Info
‘200 Level Course: Stability Program Development’ registration: $895
Specialty Course: Batch Production Records – Do’s and Don’ts
Formal Master Manufacturing Records (MMR’s) and Batch Production Records (BPR’s) have long been required in the pharmaceutical world, but the new good manufacturing practices (GMPs) for dietary supplements (21 CFR 111) bring these requirements to this industry as well. Deficiencies in MMR’s and BPR’s are among the most frequently cited during audits or inspections, including those from FDA. This course will examine common issues and pitfalls with MMR’s and BPR’s and provide specific guidance on how to avoid these problems. Best practices will be highlighted to enable your batch records withstand audits and inspections, and also streamline and improve your internal operations.
More Info
Formal Master Manufacturing Records (MMR’s) and Batch Production Records (BPR’s) have long been required in the pharmaceutical world, but the new good manufacturing practices (GMPs) for dietary supplements (21 CFR 111) bring these requirements to this industry as well. Deficiencies in MMR’s and BPR’s are among the most frequently cited during audits or inspections, including those from FDA. This course will examine common issues and pitfalls with MMR’s and BPR’s and provide specific guidance on how to avoid these problems. Best practices will be highlighted to enable your batch records withstand audits and inspections, and also streamline and improve your internal operations.
Who should attend?
This course will be useful to anyone involved in the creation, review, and/or approval of master manufacturing records (MMRs), or the creation, review, and/or approval of batch production records (BPRs) for individual lots of dietary supplements [including packaging activities]. It would also be valuable for those who have management responsibilities for any of these activities.
What you will learn:
- Understand the FDA regulatory context for MMRs and BPRs – what is required and the logic behind those requirements
- Analysis of the MMR and the process for creating them – critical factors to address to make your MMRs complete, relevant, focused and streamlined, so they drive an effective and efficient BPR process each time a batch of product is created
- Creation and use of the BPR – best practices and common shortcomings [and how to avoid those shortcomings in your organization’s BPRs]
- Tips for reviewers and approvers of both MMRs and BPRs, to make those processes both thorough and efficient
Course Outline:
- What the FDA has to say about MMR and BPR requirements through the GMP itself
- What the FDA has to say about MMR and BPR requirements through recent Warning Letters
- The purpose and audience for MMRs – and what that says about doing them right
- Critical factors and considerations to optimize your MMRs for your organization
- Key tips to get your BPRs complete and accurate the first time and every time
- Advice for optimizing the BPR review and approval process
Less Info
‘Specialty Course: Batch Production Records – Do’s and Don’ts’ registration: $599
