Dietary Supplement Training starts with a group of quality professionals capable of focusing on improving quality systems and management for your employees. A company’s most valuable assets are its people. When you choose a course with the NSF, we will provide you with a professional experienced instructor, offering their years of knowledge, insight and expertise in an interactive classroom setting.
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.
This course is geared to those individuals involved in the dietary supplement industry including those from the following areas:
October 2 & 3, 2013
8:00 AM – 5:00 PM
Cost: $1400/two day course
Irvine CA, Marriott
December 4 & 5, 2013
8:00 AM – 5:00 PM
Cost: $1400/two day course
Phoenix AZ, JW Marriott Phoenix Desert Ridge Resort & Spa
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 do 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.).
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.
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.
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. This course walks through the regulation, providing guidance on the necessary documentation and tools for compliance.
Through the Current Good Manufacturing Practices for Dietary Supplements Regulations that were enacted in June of 2007, the Food and Drug Administration 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 that they need to put in place, and the frequencies for tasks that must be performed in order to continue to comply with the regulations.
21 CFR 111 regulations require the appropriate GMP training in a facility for personnel to be conducted on a regular basis. The options for meeting this regulatory requirement include having expert consultants on-site to conduct the training on a regular basis, send personnel to external courses for training and/or develop and conduct an internal training program to meet the regulatory requirements.
This course will provide you with the insight into developing training materials, schedules and provide insights into how to integrate a culture of “quality” into your organization. Tools and resources will be provided so that delegates can implement a “quality” training program in their facility.
A company’s most precious assets are its people. Training is essential for the maintenance of high standards of quality assurance and GMP. This undeniable fact is forcefully stated by all the regulatory agencies. In the Dietary Supplement GMPs (21 CFR Part 111): 21 CFR Part 111.14(a) “You must have qualified employees who manufacture, package, label, or hold dietary supplements.”111.14© “Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person’s assigned functions.”
Globalization of the economy has provided additional market opportunities while also presenting various challenges. Navigating the various country requirements can be confusing and frustrating. This course provides an overview of the global market statistics and market potential of the nutraceutical and functional food industries. A background and history on the various countries’ legislation and responsible agencies will be provided along with country specific requirements for your company’s products to meet the necessary regulations. Regulatory frameworks for various countries will be discussed providing a comparison of how nutraceutical supplements and functional foods are defined in other countries, along with the differences or similarities between product licensing, providing standards of evidence for a product’s safety and efficacy, site licensing, good manufacturing practices and Adverse Event Reporting. The various countries that will be covered are as follows:
Possessing process control is a systematic approach to design and qualification that identifies and minimizes variation. Having this system in place provides verification that a process will perform properly and equipment will function as required. This course will provide you with the tools to successfully develop process control, design, and monitor a facility for companies producing a new product or getting a new product out on the market in compliance with GMP requirements.
This training program is designed to provide education and training to Quality Assurance/Quality Control personnel and others involved in the dietary supplement industry to facilitate not only regulatory compliance but also to develop world-class quality systems.
The training integrates relevant aspects of 21 CFR 111, ICH and USP guidelines as well as best industry practices. Specifically and practically, the training addresses critical aspects of dietary supplement matrix complexity, modern analytical testing tools, specification setting, test method selection to satisfy “fitness for purpose”, equipment qualification and quality infrastructure issues, test method design to ensure that a method is “scientifically valid”, implementation of test methods, and post-“validation” activities.
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 34856, “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.
Although 21 CFR Part 111 does not contain any specific sections that address risk assessment or risk management, risk management is an integral part of any business and is a critical component for a successful dietary supplement business. Being able to access and manage risk is critical to how a company’s policies, procedures and processes are developed and implemented. From vendor and material selection to cleaning processes and evaluating QC lab test results, risk management principles are essential to making good decisions that not only protect the quality and safety of products, but also ensure a successful business. Whether you are a contract manufacture or simply a marketer of finished products, a good risk management program based on sound principles is essential for long-term success in the industry.
Although Cleaning Validation is not required by 21 CFR 111, the principles applied in the pharmaceutical and biotech industry can be a useful tool to the dietary supplement industry to ensure the prevention of cross-contamination and potential adulteration.
Therefore, the skills obtained in this course will ensure that cleaning methods implemented in your facility will prevent the potential carryover of product, cleaning agents, impurities and potential contamination of harmful agents.
A cGMP system will have many sources of such issues: customer complaints, product non-compliances, internal deviations from specified practices, supplier problems, and results from internal, second-party or third-party audits. This course will focus on factors and techniques to enable you to turn these initially negative events into positive outcomes that will not only avoid recurrences of these problems, but strengthen your overall quality system.
Every system has things that do not go according to plan and results that do not meet expectations. A cGMP system will have many sources of such issues: customer complaints, product non compliances, internal deviations from specified practices, supplier problems, and results from internal, second-party or third-party audits. This course will focus on factors and techniques to enable you to turn these initially negative events into positive outcomes that will not only avoid recurrences of these problems, but strengthen your overall quality system.
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 dietary 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.
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 to withstand audits and inspections, but to streamline and improve your internal operations.
Jennifer graduated from Arizona State University with a Masters of Science Degree, where her research on the effects of dietary nutrients on metabolism and insulin regulation was published in the American Journal of Physiology. Jennifer is a certified clinical nutritionist and a certified strength and conditioning specialist. She is also certified in complementary medical nutrition, phlebotomy, and nutritional microscopy. Jennifer is an experienced speaker, author, and continuing education provider for health and fitness professionals and the dietary supplement industry. She is also an NSF auditor and trainer, and has been working and auditing in the dietary supplements industry for over 15 years.
Dr. Howe has 20 plus years working in production, plant management and quality for a BASF vitamin plant, providing a thorough perspective of the unique compliance issues for dietary supplement facilities and the benefits and challenges of compliance to 21 CFR 111. Dr. Howe was also instrumental in the development of the 21 CFR 111 overview course for NSF-DBA since the official release of 21 CFR 111 in June 2007. Since then, he has facilitated several of these courses beginning in 2008 for NSF-DBA.
Since 2005, Bill has been providing auditing services for NSF International of Ann Arbor, Michigan, to help them meet the needs of dietary supplement companies. Bill received a Bachelor of Science degree in chemistry from the Carroll College of Wisconsin and a M.S. Degree in Chemistry from the University of Wisconsin. Previous to working for NSF, Bill ran his own consulting, training and auditing business. Kracht was one of the first RAB-certified lead auditors in the United States and is a frequent speaker / trainer at several national and international quality conferences. He is also three-time past chairman of the International Conference on ISO 9000 and Related Standards.
Nicole has worked for NSF-DBA as a subcontract trainer and GMP consultant for a year. Nicole is a Senior Partner at Validation & Compliance Institute where she has led regulatory projects for many clients, both large and small since 2002. She has held many management positions in FDA-regulated industries, including three Vitamin production facilities at BASF. She serves as an expert witness. She is a member of ASQ and the American Chemical Society. Nicole Leitz received her ACS certified BS degree in chemistry at Hope College in Holland MI, and a MS in theoretical organic chemistry at Bucknell University under Harold Heine, PHD.
Peter has over 20 years of experience in the food law industry. Beginning in Trading Standards, he gained experience enforcing the whole range of consumer protection law and spending time in teams responsible for product safety, metrology and food safety and labeling. He has carried out routine inspections of retail and production premises, investigating consumer complaints and producing prosecution reports where required.
In 1995, Peter joined a consultancy, Law Laboratories Ltd. Concentrating on food related law, he was involved in advising on food safety, labeling and auditing of food production sites in the UK and Europe. He has also spent time on non-food product related work, including product labeling and auditing of production sites. Throughout this time he has helped design and present courses on all aspects of consumer law and its’ enforcement.
Additionally, Peter worked independently as a trading standards consultant and more specifically in the areas of product labeling, trading standards challenges and provision of trading standards related courses.
In 2009, Peter joined the consultancy NSF-CMi as Trading Law Manager looking after a team covering all aspects of Trading Law. In this role he has overseen the 5-a-Day scheme in its current format and managed a team of eight providing high quality trading law advice to clients, advising food retail and non-food retail clients on legal requirements, approving food/non-food specifications for retail sale, assessing advertising, marketing copy for legality, advising on a European basis and ensuring continuing high standards of advice and service.
Peter is a qualified ISO Lead Assessor and also holds a Masters Degree in Food Law.
Joseph Pierotti has a specialized background in analytical and natural products chemistry. He has a PhD in Natural Products Chemistry and an MS in Human Nutrition and Foods. He has over 25 years of experience in analytical methods development and validation. He has worked with QA management and laboratory staff in method implementation, interlaboratory validation, and hands-on trouble-shooting. He has developed training modules in liquid and gas chromatographic principles and applications for laboratory staff. Recently he has been a product prototype developer, phytochemistry project leader, and adjunct faculty in Chemistry at Virginia Commonwealth University. Currently he is an independent consultant in the dietary supplement industry.
Carlos has performed third party 21 CFR 111 GMP registration audits of Dietary and Nutritional Supplement manufacturing facilities in USA and Latin America, including: Vitamins, Minerals, Herbs, Botanicals, Amino Acids, Sports Supplements, Concentrates, Metabolites, and Extracts. Provide training and consulting on 21 CFR Part 210, 211 for OTCs and Pharmaceuticals, as well as CFR 111 for dietary and nutritional supplements. Dietary supplement manufacturing facilities are assessed for conformity with the NSF/ANSI 173-2010 standard. Fully conforming facilities are NSF registered as being GMP compliant and can use the NSF GMP mark.