WKM Consulting Services, LLC. is a global GXP consulting firm located in San Francisco, CA, U.S.A.

The firm was founded by Dr. Wafick Mohamed who is a quality professional with extensive GXP experience and holds top-tier degrees and certifications (D.Sc., M.Sc., B.Sc., CQA, CHRC, SSBB, PMP).

The firm provides Quality Assurance (QA), Quality Control (QC), and Quality Improvement (QI) consulting services to Pharma, Biotech, Medical Device, and Healthcare organizations.

Our services include:

QA consulting services
o Conduct GMP, GLP, GCP, TMF, and ISO audits. This includes drafting the audit agenda, conducting GXP audits, audit reports, audit observations, and audit debriefs.
o Manage vendors (CDMOs, CMOs, CROs, and CTLs) through Vendor Management Programs and procedures.
o Author SOPs, and develop processes and flowcharts.
o Review and approve master and executed batch records, forms, data packages, memos, and certificates.
o Author and manage Deviations, CAPAs, Investigations, Change Controls, Risk Assessments, Product Complaints, service agreements and contracts, and Quality Agreements.
o Manage the development and implementation of e-QMS, such as Veeva Vault QMS, Quality Doc, and LMS modules.

QC consulting services
o Review and approve master and executed QC test methods, forms, validation protocols and reports, and QC data packages.
o Author SOPs, test methods, and develop testing workflow based on FIFO principles.

QI consulting services
o Review current processes, identify gaps and waste, design and implement new efficient processes.

Project Management consulting services
o Develop project timelines and Gantt charts, lead projects, and provide regular updates the management teams.

Leadership Training
o Provide leadership and team building working sessions to executives, senior managers, and entry-level managers. 

Contact us at: 
➡️   consult@consultwkm.com
➡️   wafick@consultwkm.com
➡️   510-509-4195

WKM Consulting Services LLC

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WKM Consulting Services LLC

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Teams

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