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North American Chemical Residue Workshop (NACRW) 2014

April 9, 2014 By Steven Perez

 

ADPEN Laboratories will be exhibiting at the Annual North American Chemical Residue Workshop (NACRW) to be held July 20-23, 2014 at the TradeWinds Island Grand in St. Pete Beach, FL. ADPEN continues our tradition of attending this very important annual meeting whose purpose is to “bring scientists together to develop and validate better methodologies.”

NACRW LogoADPEN will be exhibiting in Booth 38.

Filed Under: Agrosciences, Analytical Testing News & Updates | ADPEN Laboratories, Annual Meetings Tagged With: Analytical, annual, conferences, industry, pesticide

Chinese seafood exports to face more scrutiny?

October 21, 2011 By Steven Perez

Expect more food shipments from China to the United States to face examination and potentially detention as the U.S. Food and Drug Administration implements the new Food Safety Modernization Act (FSMA), according to Benjamin England, a 17-year FDA veteran and founder and CEO of FDAImports.com and ExportToUsa.com.cn.

On Wednesday, England listed the three major challenges facing Chinese food exporters ahead of the China Fisheries; Seafood Expo, which takes place in Qingdao, China, from 1 to 3 November.

One of the three major challenges is juggling speed and quality control. “One of the toughest parts about FDA compliance from a manufacturing standpoint is that there’s always a tension between speed and quality control,” said England.

To stay competitive, Chinese companies are producing more at a faster rate. “When you do that month after month there is a risk that quality control is diminished,” he said. “because the rules are getting more complicated and production outpaces your ability to stay on top of it.” [Read more…]

Filed Under: All Services, Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links Tagged With: Analytical, detention, exports, FDA, food safety, guidance, industry, products, Testing

FDA’s New Process Validation Guidance: Industry Reaction, Questions, and Challenges

October 3, 2011 By Steven Perez

FDA’s 2011 Process Validation: General Principles and Practices guidance created a systemic shift in industry’s approaches to validation programs. The authors describe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.

In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and Practices (1). For many in the pharmaceutical industry, the guidance created a systemic shift in the expectations of their validation programs. Although the new guidance aligns process-validation activities with the product life-cycle concept and with existing harmonized guidelines such as the International Conference on Harmonization’s Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, it may have created as many questions for the industry as it has answered. In this article, the authors briefly describe the three-stage approach to validation that is outlined in the new guidance as well as implications for manufacturers regarding their current approaches to process validation. Specific emphasis is placed on questions surrounding industry implementation. [Read more…]

Filed Under: All Services, Analytical Testing News & Updates | ADPEN Laboratories, Nutraceutical Links, Pharmaceutical Links Tagged With: analysis, Analytical, FDA, GMP, guidance, industry, Testing

Florida Pesticide Residue Workshop

May 28, 2011 By Steven Perez

Visit with ADPEN at Booth #36:

48th Annual Florida Pesticide Residue Workshop (FPRW)
July 17 – 20, 2011
TradeWinds Island Grand, St. Pete Beach, Florida

Filed Under: Annual Meetings Tagged With: annual, conferences, exhibit, industry, meetings, presentation

ISO/IEC 17025 ACCREDITED

ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”. ISO/IEC 17025 is a general umbrella term used to refer to the specific standard; the current version of this standard is ISO/IEC 17025:2017. The standard contains two main sections: management requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also gives requirements related to quality management such as document control and corrective action. This standard is the basis for accreditation from an accrediting body.

ADPEN has also been inspected by the US-EPA and US-FDA multiple times with no observations.

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ADPEN Laboratories, Inc.
11757 Central Parkway
Jacksonville, FL 32224 USA

Phone: 1.904.645.9169
Fax: (904) 641-8423
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