Charles Chuck Koon

Role: Vice President at Lachman Consultant Services
Location: Morgantown, WV, US
LinkedIn followers: 500 followers

General Business & ManagementView LinkedIn profile

About Charles Chuck Koon

Specialties: Quality SystemsQuality AssuranceQuality ControlManufacturingLeadershipComplianceDue DiligenceIntegrationGXP TrainingLearning and Development Procedural DevelopmentDocument ControlChange ControlComplaintsInvestigationsIT SystemsAPR/PQRTrainingOrganizational DevelopmentProject Management21CFR 21021CFR 21121CFR 820EU GMPICHBusiness acquisitionsIntegration

Experience

Vice President
Lachman Consultant Services
Aug 2023 — Present

Education

West Virginia University
M.Sc. Environmental Safety and Health, EHS
West Virginia University
B.Sc. Animal Science

Skills

Standard Operating Procedure (Sop)
Cross-Functional Team Leadership
Biopharmaceuticals
U.s. Food and Drug Administration (Fda)
Good Laboratory Practice (Glp)
Quality System
V&V
Document Management
Biotechnology
Quality Assurance
Computer System Validation
Capa
Pharmaceutical Industry
Sop
Fda
Regulatory Affairs
Glp
Change Control
Cleaning Validation
Pharmaceutics
Validation
Regulatory Submissions
Gxp
Gmp
Technology Transfer
Due Diligence
Investigations/Capa
21 Cfr Part 11
Corrective and Preventive Action (Capa)
Regulatory Requirements
Formulation
Anda

Contact information

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Work email
•••••@lachmanconsultants.com
Personal email
•••••@•••••.com
Direct dial
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Current company

Lachman Consultant Services

Professional Services · 190 employees · Founded 1978 · Westbury, New York, United States

QUALITY | COMPLIANCE | REGULATORY AFFAIRS | DATA INTEGRITY | QMM. Founded in 1978, Lachman Consultant Services, Inc. serves companies in Pharmaceutical, Medical Device/Combination Products, Biologics, and Regulatory Affairs around the globe. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis, delivering solutions that include FDA, EMA, HPRA, and MHRA-Related Services, Audits & Mock Inspections, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, Regulatory Affairs, and Training, which consistently exceed client requirements and expectations. When it comes to compliance and regulatory affairs, Lachman has set the industry standard through senior consultants, efficient engagements, integrated expertise, and loyal clients. Global Company Website:

lachmanconsultants.com

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