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Advanced Quality Training Saves Valuable Time, Trouble and Money
“We are overly satisfied with the quality of training and consultation from the resource provided by Manufacture Nevada. The professionalism, experience, quality level and services provided by the resource are invaluable to our quality program. She was also able to provide information on food safety regulations coming down the pipeline from FDA and explain how those changes impact a dietary supplement manufacturer.”
– Liza Bitton, QA Manager, Life Enhancement
The Client
Life Enhancement Products located in Minden, NV, has an employee staff of 12 and is an innovative manufacturer of nutritional supplements with unique formulations for memory enhancement, blood sugar maintenance, thyroid support, weight control, sexual enhancement, gastrointestinal support and more.
“The company prides itself that quality is paramount. The raw materials purchased are the safest, highest-quality, pharmaceutical-grade ingredients available in the world. They are packaged under the purest possible clean-room conditions, and materials undergo lab testing to confirm purity greater than 98% (or they reject them!).”
“Innovation is their driving force. They were the first company to market DHEA, making it commercially available in the summer of 1995. They were also first to market pregnenolone, 5-HTP, vinpocetine, mastic gum, the world’s first DNA support supplement, galantamine, and now MHCP. They’ve been out there pushing the envelope and building acceptance for the enhancement of life since 1985, when the concept of life extension supplementation first gelled. Often they hear from doctors saying they really appreciate what we’re doing for this field.”
The Situation
Mr. Dale Fowkes, VP of Operations and Ms. Liza Bitton, QA Manager were working with Manufacture Nevada's Project Manager on various employee training areas utilizing a training fund program provided by the state and managed by Manufacture Nevada. Although remaining program funds were at a minimum, during one particular meeting, a desire, need and and opportunity was discussed about locating a quality resource that could provide advanced training in GMP’s, FDA regulation compliance, their existing processes; provide discussion of typical deficiencies that the FDA is finding in their industry inspections, and provide advanced training and positive reviews and recommendations on various other quality aspects related to the Nutraceutical/Supplement Industry and their operation.
They were looking to have all of this done on a very tight budget, utilizing only the training funds available, as their private budget was exhausted, and also have it conducted on site so they didn’t have the costs of travel.
The challenges Life Enhancement faced are common for a manufacturer of this discipline, in that current courses and training in these specifics offered by the industry and private organizations are high in demand and expensive; plus adding in the travel expenses, and time needed to be away from the facility far exceeded what their budget was, and what remained of their training funds would not cover even one of the courses.
Industry Courses tend to be separate in their subject matter, and are charged accordingly. If they were to attend several of these, it would have cost many thousands of dollars, plus costs and the operational impacts of their time away, both of which they could not really afford.
The Solution
Manufacture Nevada’s Project Manager, who has worked in the Industrial Food Manufacturing, Supplemental and Nutraceutical arenas for over 35 years, was able to reach into his extensive network of contacts and locate a highly reputable and well experienced resource in the food, nutraceutical and pharmaceutical industries to fulfill the needs of Life Enhancement and at the price and budget that would not make a negative impact on their finances. The resource spent a full day on site providing advanced training, reviews, updates, methodology and recommendations in GMP’s, FDA Regulation Compliance, Process Validations, Stability Studies, Discrepancy Management and CAPA(Corrective Action-Preventative Action), SOP’s, Environmental Monitoring, Raw Material Quality, FDA Warning Letters, Machine Identification, and upcoming FSMA (Food Safety Modernization Act).
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