ASQ Charleston Section 1122 November 2021 Membership Meeting 3511
ASQ Charleston Section 1122 November 2021 Membership Meeting
5
Presenter: Amy Caplette, Executive Director, Quality Assurance, Thorne Healthtech
Topic: “Regulatory Focus: Top Deficiencies for Life Sciences”

Where: WebEx, Click here to register
When: Tuesday November 23rd, 6pm-7:30pm
Speaker bio:

As Thorne HealthTech’s Executive Director of Quality, Amy Caplette is responsible for developing and leading the Quality Assurance group which includes both the Quality Assurance (QA) and Quality Control Inspection (QCI) functions. Amy is responsible for the compliance of local, state, federal, and international regulatory requirements of current Good Manufacturing Practices (cGMPs). Also, she is responsible for maintaining and improving quality systems such as Audits, Training, Root Cause Analysis, Corrective Action & Preventative Action (CAPAs), and Document Control.
Amy is the audit lead for external audits including the Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA), and the National Sanitation Foundation (NSF). Since Amy’s involvement with external audits, there has been no critical observations from the FDA, TGA, and NSF. Thorne HealthTech is regarded as a model supplement company with NSF due to low observation findings and no systemic quality issues. Amy has been instrumental with process improvements and implementation such as the revamp of the training program, quality metrics, and the material review board. In 2015, Amy led the NSF Program initiative which led to the certification of Thorne HealthTech facilities and over fifty products. This has enabled Thorne HealthTech to sell to professional athletes and Olympians. Amy has lead the implementation of an enterprise quality management software which standardizes processes and provides companywide efficiencies. Amy has developed a robust Ingredient and Supplier evaluation and approval program to ensure quality ingredients within the supply chain. In addition, Amy has streamlined job functions, championed cross-training, and promotes empowerment of staff to ensure flexibility within all Quality groups.
Amy has over 15 years of experience specializing in quality assurance and quality control of food and dietary supplements. Prior to joining Thorne HealthTech, Amy was the QA Group Leader at Amway Global. She led all aspects of quality functions including validation, laboratory testing, quality control, product quality improvement, and supplier quality improvement. Amy developed several programs such as cGMP training, Allergen management, Internal Audit, and Non-Conforming Material process that is still in existence today. She successfully led all external regulatory audits including United States (US) FDA, TGA, Korea FDA, Russia, Turkey, China, and Ukraine. She was an active member in trade association initiatives and contributed to industry guidance documents such as the “Global Guide to Good Manufacturing Practice for Supplements”. She has been a guest speaker at trade shows and expos on cGMP compliance and has contributed to several compliance articles. Amy is a certified Green Belt and has lead several successful Lean, Six Sigma, 5S, and Kaizen events which lead to cost savings and business process efficiencies. Amy lead and achieved ISO 17025 for the Amway California laboratories, and achieved year to year improvement in quality systems.
Amy received a Bachelor’s Degree in Biological Sciences from California Polytechnic University in Pomona, California.
Date & Time
Tuesday November 23rd, 2021 5:00pm CST
End Date & Time
Tuesday November 23rd, 2021 6:30pm CST
Categories
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Host Type
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Category Public Calendar

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Date & Time: 11/23/2021 06:00:00 PM EST