Du All Controls, LLC


Your Partners in Compliance


About Du All Controls, LLC

Over thirty years experience in the pharmaceutical / medical device industry. Track record of instituting and maintaining high levels of Quality Assurance, and leadership in the pharmaceutical, medical devices and biological industries. Experts in compliance, auditing, investigations, product complaint, validation, SOP development and assessment, PDMA, cGMP, CFR, document control (First Docs, Documentum, etc.), State and Government regulations, inspections, SOP Development, Quality Control, FDA Regulations, Regulatory Affairs, change control. Expertise in all industry related ISO regulations. Experience in European regulatory body regulations, Utilities/Facility and equipment validation.

Regulatory

Adverse Event Evaluation, Audits (both internal and external), GMP (Biological and Pharmaceutical) / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical – Bioanalytical / Labeling , Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA - 483 and Warning Letter Responses/Consent Decree, certified auditor, lead auditor, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, Regulatory Affairs, Regulatory Strategy Consulting, Protocol development and writing, Protocol deviations, Protocol amendment development and writing, query resolution, Reports - site visits, study reports, annual reports, review and interpret pertinent clinical data.

Technical

Guidance and Review of SAP and Oracle (ERP) Enterprise systems as they relate to the current regulations. Implement, Guidance and Review of Change Control Processes, Batch Record Review, Corrective and Preventive Action (CAPA), Document Controls, Failure Investigations, Out-of-Specification (OOS) Investigations, Preventive Maintenance, Project Management, Root Cause Analysis, Development Quality Programs, SOP Development, Technical Writing, Validation/Analytical, IQ/OQ/PQ’s for Utilities and Facilities/Medical Equipment in a manufacturing setting