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FDA Regulations and Good Manufacturing Practice (GMP) is the focus of Lean Compliance Partners, LLC
FDA Regulatory Standards, Good Manufacturing Practice (GMP), and Operational Excellence are the focus of Lean Compliance Partners, LLC. The use of Lean, ISO, quality management, training and development helps clients manage risk and reduce cost.
By: Myriam Ochart, Director
Headlines such as “Recalls and Warning Letters Still High in 2011”1 and “2011 FDA Warning Letter Review: The Rise of GMPs”2 highlight increased FDA regulatory inspections and enforcement actions.
Last Sunday, CBS News3 featured the new Ensuring Safe Medical Devices for Patients Act—a Senate bill inspired by faulty medical implants, including failure of a cardiac defibrillator implant.
No doubt the increase in public awareness of faulty medical devices will fuel sustained focus on inspections by the FDA.
Lean Compliance Partners, LLC
- Bring a combined 40+ years FDA-regulated industry experience
- Recognize the need for voluntary regulatory compliance
- Know many companies struggle with implementing the quality systems needed to meet FDA regulatory standards.
Beyond regulatory compliance, Lean Compliance Partners, LLC, offers clients expertise in streamlining client business operations using Lean methods.
- Lean improves client profit margins by reducing defects, waste, and cycle time.
- Lean allows clients to free up resources to effectively manage compliance regulatory requirements.
Lean Compliance Partners help businesses work smarter—becoming more efficient thereby fueling a company’s growth required to help companies compete successfully in today’s local and global markets.
Lean Compliance Partners (http://www.leancompliancepartners.com) integrated approach not only identifies the best strategies for businesses to streamline operations, but also simultaneously ensures full regulatory compliance.
- Compliance is simply ensuring that each product leaving a facility fulfills its intended use every time.
- Lean, traditionally seen as a cost saving tool, is actually a quality tool used to deliver the same results as a compliance system.
Recent industry news underscores that Lean and Compliance cannot be treated as separate entities without losing valuable revenue opportunities.
Lean Compliance Partners’ strategy help to break down barriers between operations and compliance to create a perfect union of Lean and Compliance, improving cycle time and increasing productivity for every client.
Myriam Ochart, Director
Lean Compliance Partners, LLC
1 “Recalls and Warning Letters Still High in 2011”, Food Safety News, Mar 26, 2011
2 “2011 FDA Warning Letter Review: The Rise of GMPs”, Nutra Ingredients-
3 “When medical implants fail”, CBS Sunday Morning segment, April 1, 2012
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Lean Compliance Partners, LLC, is a business services firm that specializes in maximizing client profit margins and product safety while minimizing their regulatory risk. Their unique integrated approach uses process reengineering tools and methodologies to remove barriers to regulatory compliance while removing process waste and increasing productivity, forming the perfect solution; the union of Lean and Compliance.
Page Updated Last on: Apr 05, 2012