Jemma Williams

Background

About Jemma Williams

J Consulting Services, Inc. is a Florida based company dedicated to providing the pharmaceutical, medical device, dietary supplement and biotechnology industries with quality, compliant, state-of-the-art services in the areas of consulting to include but not limited to creating new and or improving existing quality system, internal and external vendor audits, internal system and process audits, gap analysis for processes, training, SOP and protocol writing and execution, FDA preparedness and readiness and analytical method development/validation services. Our team of industry professionals has been servicing the Pharmaceutical and Medical Device industries for over 30 years in various roles and capacities. We have therefore developed a well-recognized reputation regarding our hands on approach and ability to work with companies as well as regulators to implement compliance initiatives to establish compliance with GMPs for pharmaceutical, medical device and dietary supplements. Our concept of project management involves the integration of individuals with varied skill-sets into multifunctional problem solving teams. This approach allows J Consulting Services, Inc. to capitalize on the broad-based industrial experience of our staff and to provide the most appropriate and cost-effective practical solutions to a particular problem. Our consultants are well-trained on internal processes and procedures and have extensive experience in the field applied industry experience as well as supporting the execution of audits that are focused on (but not limited to):o FDA Regulations and Guidanceo cGMPs under 21 CFR Parts 11, 210, 211 and 820o Inspection of Medical Device Manufacturers, Program 7382.845o Drug Manufacturing Inspections, Program 7356.002o ICH Guideso Q7 GMPs for APIo ISO Standardso 13485:2003 QMS of Medical DevicesSpecialties: • cGMP/ SOP training and compliance• CAPA Systems• Change Control Systems• Final Product Release• Quality Control in-process Release• Investigation Reports• Protocol writing• Instrument Calibration and Qualification• Laboratory Instrumentation and Methodology• Microbiological Instrumentation and Methodology• Vendor Qualification Program• Contract Laboratory Audits• Vendor Audits• Internal and FDA audits• New laboratory start up• LIMS System• Training• Validation