pathlightcompliance.com pathlightcompliance.com

pathlightcompliance.com

PathLight Compliance

PathLight Compliance Consulting provides service for FDA regulated companies to improve regulatory compliance specializing in Quality System, Quality Control, Quality Assurance, Process Validation, Computer Validation, Quality Systems, Risk Management, inspection readiness, and audit services.

http://www.pathlightcompliance.com/

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PathLight Compliance | pathlightcompliance.com Reviews
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PathLight Compliance Consulting provides service for FDA regulated companies to improve regulatory compliance specializing in Quality System, Quality Control, Quality Assurance, Process Validation, Computer Validation, Quality Systems, Risk Management, inspection readiness, and audit services.
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PathLight Compliance | pathlightcompliance.com Reviews

https://pathlightcompliance.com

PathLight Compliance Consulting provides service for FDA regulated companies to improve regulatory compliance specializing in Quality System, Quality Control, Quality Assurance, Process Validation, Computer Validation, Quality Systems, Risk Management, inspection readiness, and audit services.

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1

Facility Qualification - PathLight Compliance

http://www.pathlightcompliance.com/capabilities/facility-qualification

FDA regulations require facilities to be suitably qualified before beginning the manufacture of any drug or device intended for use in humans. From the drug CGMP regulations. Facilities in which drugs are manufactured must be of suitable size, construction, and location to facilitate proper operations ( 211.42). Room/furniture construction materials (allowing effective cleaning/disinfection). Material flow considerations (material segregation). Temperature/ humidity control capability.

2

Training - PathLight Compliance

http://www.pathlightcompliance.com/capabilities/training

As a previous training course developer for FDA's Online Training Program provided by Kaplan EduNeering, we have the expertise to provide training internally or on-line. 2011 All Right Reserved - PathLight LLC.

3

Auditing - PathLight Compliance

http://www.pathlightcompliance.com/capabilities/auditing

PathLight can provide a full review of a facility, product line, or system to determine its compliance with applicable GMP or GLP regulations. Our recommendations draw from both FDA and European regulations and guidelines to assure your firm will be compliant on a global scale. We perform all types of audits:. 2011 All Right Reserved - PathLight LLC.

4

About Us - PathLight Compliance

http://www.pathlightcompliance.com/about

PathLight is a consultancy with over 35 years of professional experience working throughout the world, serving the Pharmaceutical, Medical Device and Veterinary industries. We specialize in FDA GMP compliance,. Computer system and process validation, continuous improvement, regulatory services. To provide the highest quality, most effective compliance solutions to our client’s regulatory concerns, requirements and problems. Our Senior Team of Consultants. 2011 All Right Reserved - PathLight LLC.

5

Utilities - PathLight Compliance

http://www.pathlightcompliance.com/capabilities/utilities

FDA regulations indicate many utilities in a facility require suitable design and qualification. From the drug CGMP regulations. See sections 211.42 to 211.72). Utilities such as HVAC, water, steam, and compressed air often receive intense regulatory scrutiny during inspections. We can review and evaluate your current design plans to:. Inform you of the latest industry practices. Once your facility is up and running, we can help you validate and monitor its effectiveness. Set up a data trending program.

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Let us Light your PATH to compliance! LLC is a compliance consulting company that can help guide your FDA regulated company toward complete regulatory compliance by focusing on Quality Systems, Quality Control, Quality Assurance, Process Validation, Computer Validation, Risk Management, training, and auditing. We can help your company implement or improve your Quality System (see our Pharmaceutical Technology article. 2011 All Right Reserved - PathLight LLC.

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