WKM Consulting Services LLC

WKM Consulting Services LLC

Operations Consulting

San Francisco , CA 682 followers

Biotech and Pharma Consulting Services Quality Assurance | Quality Control | GxP Audits

About us

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, CSSBB, 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 via Microsoft Project and Smartsheet o Develop project presentations and flowcharts for project teams and senior management teams. Leadership Training o Provide leadership and team building working sessions to executives, senior managers, entry-level managers, and supervisors. Contact us at: ➡️ wmohamed@uab.edu ➡️ 510-509-4195 Thank you!

Website
https://wkmconsultingservices.carrd.co/
Industry
Operations Consulting
Company size
2-10 employees
Headquarters
San Francisco , CA
Type
Privately Held
Founded
2024

Locations

Updates

  • Dear WKM Clients, As we welcome the new year, I wanted to take this opportunity to extend my warmest wishes for a happy and prosperous 2025 to you and your families. It has been a pleasure working with you throughout 2024, and I want to express my sincere gratitude for your continued trust and partnership. Your unwavering support has been invaluable to us, and we truly appreciate the opportunity to collaborate with you on various Quality and Compliance consulting projects. As we look ahead to the upcoming year, we are excited about the prospect of continuing our partnership and exploring new opportunities for growth and success together. WKM Consulting Services LLC is committed to delivering the highest level of Quality and Compliance service and expertise to meet your evolving needs and objectives. I would like to thank you once again for your ongoing support and trust in our services. Your satisfaction is our top priority, and we are always here to assist you in any way we can. Wishing you, your teams, and families a joyous holiday season and a bright start to the new year. May 2025 bring you prosperity, good health, and success in all your endeavors. Warm regards, Dr. Wafick Mohamed D.Sc., M.Sc., CQA, PMP, CLSSBB. Founder | CEO | Principal GXP Consultant ______________________ 📩 Request Free GLP, GCP, GMP Quality consultation: E-mail: wmohamed@uab.edu, drwafick@gmail.com Phone: 510-509-4195 We offer the following Quality consulting services: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ GLP, GCP, and GMP Audits 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. #WKM #Consulting #Services #WKMconsultingservices #HappyHolidays #Happy2025 #Happynewyear #NewYear #RequestServices #Hire #Freelancers

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  • 🎗️FDA Just Released🎗️ The FDA just released guidance for the industry titled “Consideration for Complying with 21 CFR 211.110”. The guidance aims to ensure Batch Uniformity (BU) and drug product integrity. Additionally, the document aims to provide guidance on quality considerations for drug products manufactured via advanced manufacturing processes or technologies! 📚 The final guidance is attached below ↓ 🎗️Let us Collaborate🎗️ WKM Consulting Services LLC provides top-notch Quality and Compliance consulting services that include: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ GLP, GCP, GMP, and ISO Audits ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ Internal mock inspections ➡️ Inspection readiness training ➡️ Comprehensive gap assessment (FMEA, Risk Assessment, and SWOT analysis) of your systems, processes, and procedures. 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. 📩Get your free consultation: ➡️ E-mail: wmohamed@uab.edu, drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you 🙏 #WKM #WKMConsultingServices #RequestaService #Audits #WKM #Consulting #Services #FDAregulations #Regulations #FDA #BatchUniformity #drugproductintegrity #guidance #quality #requestconsultingservices

  • 🎗️FDA Just Released🎗️ FDA just released manufacturing guidance titled “Advanced Manufacturing Technologies Designation Program Guidance for Industry” The guidance aims to explain the benefits of advanced technology and encourages its utilization which could enhance the reliability of the manufacturing process and supply chain, and increase timely access to high-quality medicines. This will result in a reliable supply of drugs that can save or enhance the life of patients worldwide. 👉AMTs can directly improve product quality (e.g., through better manufacturing controls and fewer human interventions). 📚 The final guidance is attached below ↓ 🎗️Let us Collaborate🎗️ WKM Consulting Services LLC provides top-notch Quality and Compliance consulting services that include: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ GLP, GCP, GMP, and ISO Audits ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ Internal mock inspections ➡️ Inspection readiness training ➡️ Comprehensive gap assessment (FMEA, Risk Assessment, and SWOT analysis) of your systems, processes, and procedures. 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. 📩Get your free consultation: ➡️ E-mail: wmohamed@uab.edu, drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you 🙏 #WKM #WKMConsultingServices #RequestaService #Audits #WKM #Consulting #Services #FDAregulations #Regulations #FDA #inspection #ICH #NIST #Collaboration #expeditedPrograms #AcceleratedApproval #Drugs #Biologics #USFDA #warningletters #CodeofFederalRegulations #CFR #ATM #Manufacturing #AdvancedTech #technology

  • 🎗️Regulatory Release Alert🎗️ FDA just released “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” guidance for industry.   📚 The final guidance is attached below ↓ 🎗️Let us Collaborate🎗️ WKM Consulting Services LLC provides top-notch Quality and Compliance consulting services that include: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ GLP, GCP, GMP, and ISO Audits ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ Internal mock inspections ➡️ Inspection readiness training ➡️ Comprehensive gap assessment (FMEA, Risk Assessment, and SWOT analysis) of your systems, processes, and procedures. 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. 📩Get your free consultation: ➡️ E-mail: wmohamed@uab.edu, drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you 🙏 #WKM #WKMConsultingServices #RequestaService #Audits #WKM #Consulting #Services #FDAregulations #Regulations #FDA #inspection #ICH #NIST #Collaboration #expeditedPrograms #AcceleratedApproval #Drugs #Biologics #USFDA #warningletters #CodeofFederalRegulations #CFR #FDA #FDAwarningletters #Regulatorycompliance #Pharmaceuticalregulations #NDA #IND #PLA #BIMO #inspection #electronicsubmission #EMA #GCP #InspectorReport #Rarediseases #guidance #ptotocol #deviations #drugs #devices #biologics

  • I want to work from home! Researchers have invested time and effort in studying whether working from home (WFH) has a positive impact on productivity and employee satisfaction. However, the results of these studies have been inconsistent. Some researchers argue that working from home leads to less productive employees due to reduced support and oversight. They also note that WFH can create bottlenecks in workflow patterns with colleagues and customers. Additionally, face-to-face interactions are seen as beneficial for both employers and employees. On the other hand, some researchers suggest that WFH actually enhances productivity and performance by improving work-life balance. They attribute increases in employee satisfaction and engagement to the WFH model. Furthermore, studies have found that working from home can result in cost savings for both employees and employers. ✴️ Which side do you support: working from home or on-site employment❓ References: Gibbs, M., Mengel, F., & Siemroth, C. (2021). Work from home & productivity: Evidence from personnel & analytics data on IT professionals. University of Chicago, Becker Friedman Institute for Economics Working Paper, (2021-56). Daniel Garrote Sanchez, Nicolas Gomez Parra, Caglar Ozden, Bob Rijkers, Mariana Viollaz, Hernan Winkler, Who on Earth Can Work from Home?, The World Bank Research Observer, Volume 36, Issue 1, February 2021, Pages 67–100, https://lnkd.in/gisvzWRX. Demerouti, E., Geurts, S.A.E. and Kompier, M. (2004), "Positive and negative work‐home interaction: prevalence and correlates", Equal Opportunities International, Vol. 23 No. 1/2, pp. 6-35. https://lnkd.in/guPpWMdi. ———————————————— 📩 Get your free consultation:   ➡️ Email: wmohamed@uab.edu, drwafick@gmail.com   ➡️ Phone: 510-509-4195 👉 We offer the following services: ➡️ Quality Control (QC)   ➡️ Quality Assurance (QA)   ➡️ Vendor Management (VM)   ➡️ System Validation (SV)   ➡️ Project Management (PM)   ➡️ GLP, GCP, GMP, and ISO Vendor Audits   ➡️ Internal Mock Inspections   ➡️ Inspection Readiness Training   ➡️ Comprehensive Gap Assessments (FMEA, Risk Assessment, and SWOT analysis) of your systems, processes, and procedures. 📲 Follow our LinkedIn page, "WKM Consulting Services LLC," to stay updated on new regulatory changes. #WKM #Consulting #Services #WKMConsultingServices #FreeConsultation #RequestServices #WorkFromHome #WFH #Productivity #EmployeeSatisfaction #satisfaction #worklifebalance #vote #poll #pollvote #survey

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  • As we near the end of 2024, we at WKM Consulting Services LLC take a moment to reflect on the outstanding year we've had since our founding. We have achieved remarkable success in the Pharma/Biotech consultancy industry. 🎗️ About WKM Consulting Services LLC 🎗️ ➡️ Founded and launched on January 9, 2024. ➡️ Assembled an exceptional global team of GXP Quality experts ➡️ Our LinkedIn page gained over 600 followers in less than three months. ➡️ We have signed Service Agreements with three major Biotech clients. ➡️ We have scheduled 7 GXP audits and a significant Veeva Vault project for 2025, even while still in 2024. We appreciate your business and are honored to support you in achieving your goals. We look forward to a productive 2025 filled with collaborations, positive experiences, excellent customer service, and celebrations of our shared success. 👉 New to WKM Consulting Services?   Let us help you achieve your Quality and Compliance goals! 📩 Get your free consultation:   ➡️ Email: wmohamed@uab.edu, drwafick@gmail.com   ➡️ Phone: 510-509-4195 👉 We offer the following services: ➡️ Quality Control (QC)   ➡️ Quality Assurance (QA)   ➡️ Vendor Management (VM)   ➡️ System Validation (SV)   ➡️ Project Management (PM)   ➡️ GLP, GCP, GMP, and ISO Vendor Audits   ➡️ Internal Mock Inspections   ➡️ Inspection Readiness Training   ➡️ Comprehensive Gap Assessments (FMEA, Risk Assessment, and SWOT analysis) of your systems, processes, and procedures. 📲 Follow our LinkedIn page, "WKM Consulting Services LLC," to stay updated on new regulatory changes. 🎄 Wishing you a Merry Christmas and a Happy New Year! 🎄 #WKM #Consulting #Services #WKMConsultingServices #HappyHolidays #MerryChristmas #HappyNewYear #RequestServices #FreeConsultation #QualityExpert

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  • 🎁Christmas Surprise🎁 As we approach the end of 2024, we reflect on the outstanding year that WKM Consulting Services LLC has had since its founding. We have experienced remarkable success in the Pharma/Biotech consultancy industry. 🎗️About WKM Consulting Services LLC. ➡️ Founded and launched on January 9, 2024. ➡️ Our LinkedIn page grew to over 600 followers in less than three months. ➡️ Signed Service Agreements with three major clients. ➡️ Scheduled 7 GXP audits and a major Veeva Vault project in 2025 while still in 2024. To express our gratitude to our clients, we are excited to celebrate the season by offering the following gifts: - A large WKM Consulting shopping bag - A WKM Consulting coffee mug - A WKM Consulting notebook - A WKM Consulting pen - A $100 Starbucks gift card These gifts are a small token of our appreciation for your support. We look forward to a productive 2025 filled with collaborations, positive experiences, excellent customer service, and celebrations of our shared success. Let us help you achieve your goals! 📩Get your free consultation: ➡️ E-mail: wmohamed@uab.edu drwafick@gmail.com ➡️Phone: 510-509-4195 👉 We offer the following services: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ GxP Vendor Audits ➡️ Internal Mock Inspections ➡️ Inspection Readiness Training ➡️ Comprehensive Gap Assessments, FMEA, and Risk Assessments of your systems, processes, and procedures. 📲 Follow our LinkedIn page, "WKM Consulting Services LLC," to stay updated on new regulatory changes. 🎄 Wishing you a Merry Christmas and a Happy New Year! 🎄 #WKM #Consulting #Services #WKMConsultingServices #HappyHolidays #MerryChristmas #HappyNewYear #RequestServices

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  • Get Your Free Consultation! WKM Consulting Services LLC offers top-notch Quality and Compliance consulting services for Pharmaceutical, Biotechnology, Therapeutics, Medical Device, and Healthcare Organizations. Our services include: - Quality Control (QC) - Quality Assurance (QA) - Vendor Management (VM) - System Validation (SV) - Project Management (PM) - GLP, GCP, and GMP vendor audits - Internal mock inspections - Inspection readiness training - Comprehensive gap assessment (Risk Assessment, FMEA, and SWOT Analysis) of your electronic systems, processes, procedures, and operations. Follow our LinkedIn page “WKM Consulting Services LLC” to stay updated on new regulatory changes. Get your free consultation: ➡️ E-mail: wmohamed@uab.edu drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you! #Free #Consultation #FreeConsultation #SOP #StandardOperatingProcedure #Policies #QMS #Forms #WKM #WKMConsultingServices #RequestaService #Audits #Consulting #Services #Requestfreeconsultation #QA #QC #ClinicalQA #VendorManagement #GXPaudits #Projectmanagment

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  • 🎗️Regulatory Release Alert🎗️ FDA released a new guidance to help sponsors create successful drug development programs that address the various challenges posed by rare diseases. The guidance encourages sponsors to engage early with the Agency to discuss their drug development program to ensure the successful development of their drugs! Link to guidance ➡️ https://lnkd.in/eARpU-zg    📚 The final guidance is attached below ↓ 🎗️Let us Collaborate🎗️ WKM Consulting Services LLC provides top-notch Quality and Compliance consulting services that include: ➡️GxP vendor audits ➡️ Internal mock inspections ➡️ Inspection readiness training ➡️ Comprehensive gap assessment, FMEA, and Risk Assessment of your systems, processes, and procedures. Additionally, We offer the following consulting services: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ Toxicology 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. 📩Get your free consultation: ➡️ E-mail: drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you 🙏 #WKM #WKMConsultingServices #RequestaService #Audits #WKM #Consulting #Services # FDA #Regulations #FDA #inspection #ICH #NIST #Collaboration #expeditedPrograms #AcceleratedApproval #Drugs #Biologics #USFDA #warningletters #CodeofFederalRegulations #CFR #FDA #FDAwarningletters #Regulatorycompliance #Pharmaceuticalregulations #NDA #IND #PLA #BIMO #inspection #electronicsubmission #EMA #GCP #InspectorReport #Rarediseases #guidance

  • 🎊Big Surprise🎊 WKM Consulting Services LLC would like to express appreciation to our clients this holiday season. 🙏🏼 Surprises 🎁 are on the way from us, stay tuned! 🎗️WKM Consulting Services LLC.🎗️ 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. 📩Get your free consultation: ➡️ E-mail: drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you 🙏 #WKMConsultingServicesLLC #WKM #Consulting #PharmaConsulting #BiopharmaConsulting #Consultants #Holiday #Holidayseason #Gifts #Surprises

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