TEDMED ENGINEERING & PROJECTS

The benefits of hiring a regulatory consultant expert, who has a medical device engineering background is being able to successfully audit your equipment processes before an FDA, IRB, ISO site or other regulatory audit inspection. You need to asset managed all your research equipment. How? 1. Hire a consultant to asset tag and inventory manage your site equipments. 2. They can also do equipment impact assessment evaluations, to determine which of your equipment requires validation to help you stay in compliance. 3. Hire a consultant to perform a regular Preventative Maintenance and Calibration. You need to have a PM report on each equipment indicating your equipment has been checked. CRA’s, ISO / FDA inspectors or other site inspectors will request this. 4. Put a PM inspection tag on all equipment with the next due date. 5. Hire a consultant to perform temperature mapping validation on freezers and refrigerators as part of your validation and also capture the PM as part of the validation. 6. Monitor the temperature on your freezers and refrigerator, if you have products in it. Inspectors will ask for monitoring records. 7. If you move an equipment that had product impact, perform a revalidation. As a consult, I perform all services listed here. Elizabeth Bonsu, Regulatory Consultant Experts Regulatory, Quality, Validation Engineering, Clinical Research Project Management BSBE, MSME, PMP ISO, GMP, GLP & GCP Auditing https://lnkd.in/e3tDpDDq

https://lnkd.in/d5JBb4Ua Let talk about Validation in the ISO certified and GMP environment - my correction- Good Manufacturing Practices. Why do you need a Validation Engineer Consultant ? Let talk

Happy birthday Elizabeth. We celebrate 42 years with you. Thank you for your hard work and dedication.

Happy birthday Elizabeth. We celebrate 42 years with you. Thank you for your hard work and dedication.

TEDMED Engineering, & Projects are a team of Regulatory Professional, and Project Management Consultants with over 16 years of experience in the Biotechnology, Pharmaceutical and Distribution Industry. ? ? We specialized in Medical Device Validation, Quality Engineering, Medical Device Asset Management and Project Management. ? For Medical Device Asset Management: ? We perform Equipment Installation, Preventative Maintenance (PM) and Qualification. We write and execute PM procedures and manage all equipment lifecycle. ? For Validation Qualification Services (IQOQPQ): ? We offer Computer System Validation, Software Validation, Equipment Validation, Facility Validation, Process Validation, Temperature Mapping Validation and Printing, Packaging and Labelling Validation. We write the IQOQPQ protocol and execute it. We also provide summary report of the execution. ? For Quality Services: ? We manage all QMS system.? We write CAPA’s, NCR and managed DCR’s and SOP’s. ? For GCP Clinical Research Services: ? We Oversee TMF audits, investigator site audits, and Risk-Based Quality Management. We project managed phase I-IV protocols according to the sites monitoring plan and procedures. We also perform onsite and remote PSV, SIV, IMV, Pre-audit, and Booster visit. Generated PSV, SIV, IMV, Confirmation Letter (CL), Follow-Up-Letter and Closeout (COV) Report. I will like to set a meeting to discuss how best we can assist your company. TedMed Engineering & Projects,TMEP & TMEP Divinity Research Center Personal: 404-641-0047 | 678 689-4046 Office: (877) 255-7660 | (404) 475-2591 www.tedmedengineering.com