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MYERSQC.COM

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Myers Quality Consulting specializes in GCP/GLP auditing and compliance with experience in other FDA regulated industries

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Myers Quality Consulting specializes in GCP/GLP auditing and compliance with experience in other FDA regulated industries
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Home | GLP Auditing | myersqc.com Reviews

https://myersqc.com

Myers Quality Consulting specializes in GCP/GLP auditing and compliance with experience in other FDA regulated industries

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1

Nonclinical Laboratories | GLP Audit

http://www.myersqc.com/audits/nonclinical-laboratories

Clinical Investigator Site Audits. During a GLP audit, we evaluate:. Equipment calibration and maintenance. Test and control articles. Validation of computerized systems. Audits conducted during the live phase of the study can identify potential issues before completion of the study. Sponsors can be assured that contracted services are sufficient to support the requirements of the protocol. Proudly powered by WordPress.

2

Resources -

http://www.myersqc.com/resources

Clinical Investigator Site Audits. Good Clinical Practice in FDA-Regulated Clinical Trials. Compliance Program 7348.001 Bioresearch Monitoring: Human Drugs In Vivo Bioequivalence. Compliance Program 7348.808 Bioresearch Monitoring: Good Laboratory Practice. Compliance Program 7348.809 Bioresearch Monitoring: Institutional Review Board. Compliance Program 7348.810 Bioresearch Monitoring: Sponsors, Contract Research Organizations and Monitors. ICH E6: Good Clinical Practice: Consolidated Guidance.

3

Regulations | GLP Audit

http://www.myersqc.com/key-regulations-guidances

Clinical Investigator Site Audits. Are you in compliance with these critical regulations? ICH-E6 Good Clinical Practice. ICH Q9 Quality Risk Management. ICH Q10 Pharmaceutical Quality System. European Commission (EC) 2001/20/EC. 21 CRF Part 11 Electronic Records; Electronic Signatures. 21 CFR Part 50 Protection of Human Subjects. 21 CRF Part 54 Financial Disclosure by Clinical Investigators. 21 CFR Part 56 Institutional Review Boards. 21 CRF Part 312 Investigational New Drug Application.

4

FDA Inspection Readiness | GCP Audit

http://www.myersqc.com/audits/fda-inspection-readiness

Clinical Investigator Site Audits. We can come into your office and work with your employees to prepare for the best possible outcome. Our clients for FDA inspection readiness audits include:. Mock inspections provide an opportunity to coach employees during interviews. Fine tune logistical plans. Ensure records are readily available. Refresh key individuals on the project. Identify any issues which might have been missed. Proudly powered by WordPress.

5

Gap Analysis | GLP Audit

http://www.myersqc.com/audits/gap-analysis

Clinical Investigator Site Audits. Gap Analysis can be performed to identify gaps in the current quality system and established processes. Identifies shortcomings in the quality system. Provides an opportunity to optimize quality systems. A gap analysis was performed comparing the existing written procedures against the regulatory requirements for an accreditation inspection. Additional procedures were written or revised to strengthen processes and the company received their accreditation.

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Clinical Investigator Site Audits. Myers Quality Consulting specializes in GCP/GLP auditing and compliance with experience in other FDA regulated industries. Clients range from startups to large, global companies in the pharmaceutical, biotechnology, biologics, in vitro diagnostics and medical device industry. We can tailor our services to fit your business needs. Proudly powered by WordPress.

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Home | GLP Auditing

Clinical Investigator Site Audits. Myers Quality Consulting specializes in GCP/GLP auditing and compliance with experience in other FDA regulated industries. Clients range from startups to large, global companies in the pharmaceutical, biotechnology, biologics, in vitro diagnostics and medical device industry. We can tailor our services to fit your business needs. Proudly powered by WordPress.

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