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REQUESTED EXPERTISE PROJECT DESCRIPTION SUCCESSES & DELIVERABLES
21 CFR Part 210, 211 & 820; Auditing, Quality System Conducted Mock FDA Audits for worldwide Drug & Device Manufacturing Operations in response to consent decree for fortune 100 Drug company. Provided firm with Audit reports, 483 style findings and Corrective Action Plans
>21 CFR 820; Quality System, Software Life Cycle Development Conducted Mock FDA Audits of Device Development, Blood Operations and  Software as  a Medical Device for Large Biologics Manufacturer Provided firm with Audit reports, 483 style findings and Corrective Action Plans
21 CFR 820, 606, Part 11; Quality System, Software Life Cycle Development Conducted Mock FDA Audits of Device Development & Manufacturing and Blood Banking Operations. Audit development and validation of Software as a Medical Device and operational and quality system software for nation’s larger blood supplier. Provided firm with Audit reports, 483 style findings and Corrective Action Plans
21 CFR Part 820; Purchasing Controls Develop and implement a Purchasing Control (Supplier Management) system for nation’s larger blood supplier. Developed and implemented SOPs, WI and Forms and provided Training on CAPA and Purchasing Control.
21 CFR 820; CAPA, Problem Solving, Organizational Development, CAPA Software Develop and implement a CAPA system for nation’s larger blood supplier. Facilitated project team, developed and implemented CAPA SOP, WI, Forms and Database. Train on Problem solving, CAPA, Quality System & Listening Skills.
21 CFR 210, 211 & 820 Develop and Review Process & Equipment Validation Protocols & Reports for large biologics and drug manufacturer. Prepared and delivered Validation Summary Reports and Corrective Action Plans.
21 CFR 820; Quality System Conduct Mock FDA Audit of Device manufacturing subcontractors for  large biologics and drug manufacturer. Provided firm with Audit reports, 483 style findings and Corrective Action Plans.
21 CFR 820; Review Product Complaints and develop Remediation and Compliance Assessment Strategy for large IV solutions and IV pump manufacturer. Prepared and delivered assessment report and QSR strategy.
21 CFR 210, 211 & 820 Train on 21 CFR 210, 211 and on differences to 820 at worldwide sites. Audit device manufacturing sites to determine readiness for compliance to 21 CFR Part 210, 211 for large needle and syringe device manufacturer. Prepared and delivered Training Presentations on 21 CFR Parts 210, 211. Provide 210, 211 Compliance Readiness report.
21 CFR 820; Quality System Conducted Mock FDA Audits for Device Development & Manufacturing Operations in response to Warning Letters, 483 & Consent Decree. Conduct Management Assessment for large fortune 500 drug and device manufacturer. Provided firm with Audit reports, 483 style findings and Corrective Action Plans.
21 CFR 820; Product Complaint Handling Review historical complaint records to assess risk and reporting compliance.

Provided Complaint Assessment Report.
21 CFR 820; Design Control; Software Development Lifecycle Design & Implement a worldwide multi-site Design Control System for leading manufacturer of respiratory devices. Train on Quality System Regulation and Design Control. Developed and facilitated Design Control lead team and a State-of-the-Art design Control Process. Provided SOPs, WI, Forms and Templates. Conducted training on Design Control and Quality System Regulations. Prepared a Design Control Plan.
21 CFR Part 11; FDA’s Guidance on Computerized Systems, ICH E6 Good Clinical Practice Review Historical Audit Reports and Conduct Audit of Software being used for Clinical Trials for leading University Medical School. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820, 600; Design Control, Process Control; Six Sigma, SPC, DOE Conduct Assessment, Review and Revise Practices and Procedures on Risk Analysis, Design Control and Process Validation for Artificial Liver device and supporting Biologics. Provide general consulting on Continuous Improvement activities. Provided Design Control and Process Validation Plans, reviewed and revised Process Validation and Design Control Procedures. Conducted Training on Statistical Process Control and Design of Experiments
21 CFR 820; Quality System Develop comprehensive Quality System for startup Medical Device (software & hardware) manufacturer. Delivered Quality Manual, and comprehensive set of SOPs, Work Instructions, Forms and Templates. Configured and implemented Pilgrim Quality System software.
21 CFR 820; Design Control; ISO 13485 Audit Design Control documentation for new device Project Dossier for CE Mark and 510 K Approval for Catheter Manufacturer. Provided Review Summary Report at conclusion of Audit.
21 CFR Part 820, 210, 211 Conduct Audit of Combination Product s(Insulin Pen) Development and Manufacturing Operation for large fortune 100 drug manufacturer. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR Part 210, 211 Conduct Audit of Validation activities for new Drug Manufacturing Plant. Prepare and facilitate the implementation of a Remediation Plan for large fortune 100 drug manufacturer. Provided firm with Audit report, 483 style findings and Remediation Plan. Managed a team of seventeen consultants to implement Drug Quality System review and revise process and equipment validation protocols and reports.
21 CFR Part 820, 210, 211; Quality System, Design Control Conduct Audit, Develop and Implement Remediation Plan for Combination Product Development for large fortune 100 drug manufacturer. Provided firm with Audit report, 483 style findings and Remediation Plan. Provided Quality Manual and comprehensive set of Quality System SOPs.
21 CFR Part 820, 210, 211; Quality System Develop Product Complaint Handling and Reporting system for Combination Products for large fortune 100 drug manufacturer. Facilitated team to develop and implement SOPs, WI and Forms for Product Compliant Handling.
21 CFR Part 820, 210, 211; Quality System Develop Purchasing Control Process for large fortune 100 drug manufacturer. Provide Purchasing Control SOP, WI and Forms.
21 CFR 820, 210, 211; Quality System Conduct Audit of International Subcontractor Sites for Manufacture of Injectable Pen for large fortune 100 drug manufacturer. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820; Quality System Conducted Mock FDA Audits of Device Manufacturing Operations in response to Consent Decree for small device manufacturer. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820; Quality System Develop Quality System SOPs for medium size device manufacturer. Provided Quality System SOPs
21 CFR 820; Design Control Conduct Audit of Product Development Activities for IVD Product in Italy for large US based Drug Manufacturer. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 210, 211; GMP; Laboratory Controls; HPLC Analysis Conduct Investigation into Impurities Results for HPLC Analysis of OTC Products. Review Historical Filling and Packing Batch Records. Prepare 483 Responses with Corrective & Preventive Action. Provide Impurities Review Analysis Reports, Batch Record Review Reports, 483 Responses. Provided Automated and Validated  Spreadsheet for Impurities Calculations.
21 CFR Part 820; Quality System, Six Sigma, Document & Records Controls Design & Implement Document & Records Control System. Audit Software Development process. Conduct Training on New Document & Records Control system at worldwide sites (Diabetes related Device) for large fortune 500 device manufacturer. Facilitated team to design and implement a Document & Records Control System. Developed State-of-the-Art Decision tool for Approval Process. Conduct Training on Document & Records Control.
21 CFR 820; Quality System Conduct Quality System Audit of multiple device and component subcontractors’ manufacturing sites (Catheters). Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820; Quality System Conduct Quality System Audit of multiple device and component subcontractor development and manufacturing sites (Catheters). Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820; Quality System Conduct Audit of Quality System and develop Remediation Plan for large Japanese device manufacturer.< Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820 Conduct audit of Tobacco Manufacturing Processes at multiple Sites versus quality System Regulations for fortune 100 company. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820 Develop Design Control Process for Tobacco product Development. Train on Design Control and Quality System Regulations. Developed Design Control SOPS, WI, Forms and Templates and conducted training on Design Control and Quality System Regulations.
21 CFR 820 and Related FDA Guidance on Software used in Clinical Trails Conduct Audit of use and Implementation of Software used for Clinical Trials. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820; Conduct Audit of Quality System and develop Remediation Plan for large diagnostics and laboratory testing company. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR Part 820, 210, 211; Design Control Audit Design Control activities for development of a combination product (Injectable pen) and implement a remediation plan for large drug company. Provided audit report of Historical Design History File and Created new Design History File for product. Developed and provided Design Verification and Validation Summary Report, Design Transfer Plan and a comprehensive Design Review Template Package.
21 CFR 820; Quality System Conduct Audit of Quality System and develop Remediation Plan for International manufacturing sites of Dental Implant Devices for US based dental device manufacturing company. Provided firm with Audit report, 483 style findings and Corrective Action Plan.
21 CFR 820; Quality System Conduct Audit of Quality System and develop Remediation Plan for In-vitro Diagnostic Devices. Provided firm with Audit report, 483 style findings and Corrective Action Plan. Revised and developed Quality System SOPs for CAPA, OOS, Product Complaint Handling, Design Control and Management Controls. Conducted training on QSR, CAPA, Design Control etc.
21 CFR 210, 211 Create Job Descriptions for entire Quality Organization. Review, Investigate, Document and Close out Deviations backlog for compressed tablets manufacturing line for large drug company. Provided industry equivalent Job Descriptions. Prepared Deviation reports for approval and closeout.
21 CFR 820 Facilitate Problem Solving to investigate and resolve top ten complaints for respiratory devices for large European Medical Device manufacturer. Created comprehensive CAPA files for top ten complaints for closeout.
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