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PSC Biotech - Audit Utopia
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- 2. For over twodecades we have organically grown our consultancy to a worldwide business with operations in North America, Latin America, Europe, Asia, and the Middle East. This global footprint helps us service our large, multinational clients in ways that smaller, regional competitors cannot. This also affords us a global perspective on where the life sciences market is going and how to most effectively position our company to meet both current and future trends. Why PSC Biotech™? biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 3. We’re proud towork with some of the top life science companies around the world. From medical device to naturopathic, we have the expertise to fit your needs. We’re also proud to have worked with companies from their infancy and through their growth, supporting them when and where they need us. Our Client Base biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 4. For over twodecades we have organically grown our consultancy to a worldwide business with operations in North America, Latin America, Europe, Asia, and the Middle East. This global footprint helps us service our large, multinational clients in ways that smaller, regional competitors cannot. This also affords us a global perspective on where the life sciences market is going and how to most effectively position our company to meet both current and future trends. Worldwide Audits: Global Footprint With Regional Expertise biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 5. PSC Biotech™ hasextensive experience in auditing GxP companies – from assisting companies with an upcoming pre-approval inspection to third-party suppliers and testing facilities. Our staff of seasoned professional auditors has experience with the FDA, ISO, and international regulatory agencies. Audited Companies biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 6. Audit Services: ClientCompliance Support • 483 / Warning Letter remediation • QA Review (GLP, GMP, GCP) • Risk Assessments • EM Program Analysis/Creation • Microbiology Laboratory Consulting • Supply Chain Evaluation • Specialized Support Remediation Support • On-Site Auditing • Finish Fill CMO’s • API Manufacturers • Excipient Manufacturers • General Chemical • Secondary Packaging • Primary Packaging • Paper Auditing (Questionnaire Management) • Supplier Qualification • Turn Key Supplier Management Program Supplier/Vendor Management• Mock Pre-Approval Inspections (PAI) and mock FDA audits • Mock Notified Body Inspections • Quality system & corporate SOP gap analysis • Data Integrity Audit • Mock recalls • Formal risk assessments & risk mitigation strategies Internal Auditing Experts in Regulations: • GMP • GLP • FDA 210/211 • FDA 820 • FDA Part 11 • FDA 225 • 10 CFR 50 & Appendix B • FSMA • ICH Q7 • ICH Q10 • EU Guidance • GAMP • ISO 9001 • ISO 13485 • ISO14001 • ISO172025 • ISO 45001 • IATF 16949 • AS9100 • NQA-1 1 2 3 biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 7. Audit Services: ClientCompliance Support Cont. • Supplier questionnaire submitting • Grading • Risk Assessment • Supply Chain Support • Supplier Training • Full Turn Key Plans Available Full Service Management • Industry Experts: • PDA • ASQ • RAPs • ISPE • Internal Training • Continuous Training • Client Required Training for Dedicated Client Programs - Available Auditor Training • Years of experience • Auditor Selection based on all Audit Criteria • Dedicated Auditors are available • Specialized Auditors Auditor Selection Experts in Regulations: • GMP • GLP • FDA 210/211 • FDA 820 • FDA Part 11 • FDA 225 • 10 CFR 50 & Appendix B • FSMA • ICH Q7 • ICH Q10 • EU Guidance • GAMP • ISO 9001 • ISO 13485 • ISO 14001 • ISO 172025 • ISO 45001 • IATF 16949 • AS9100 • NQA-1 4 5 6 biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768
- 8. Audit Services: AuditProcess biotech.com | info@biotech.com | 700 Corporate Center Drive Pomona, California 91768 Audit Reputation • Trusted partners • Follow up on findings • Global Experts • Speed • Repeat Customer 1 2 Auditor selection Made through website or sales Audit report and continued support Audit performed 3 4 Request Selection Execution Completion PSC proposal sent will outline: • Type of Audit to be performed • Location • Auditors Qualification/Selection • Length of Audit • Special Request needs
- 9. Audit Management Software AUDITUTOPIA AuditUtopia™is a realtime inspection management system for tracking and managing inspections, trusted by life science companies worldwide. Many organizations choose AuditUtopia™ as the center of their inspection team to seamlessly streamline group efforts to improve response time for inspection requests. AuditUtopia Benefits: • Accessible anywhere • 100% request tracking • Real-time updates • Report generation for requests • Metrics & charts generation • Complete auditor archive • Incomplete inspection data capture • Insecure communication • “Where is the data?” • “Where is it now?” • Lost and incomplete request response • Slow response time AuditUtopia Prevents: Automated Reports Runners Pro- Active Printing Doc Shredding Workflows End of Day Meetings Travel FedEx Raw Person hoursScribe
Editor's Notes
- #2 Welcome everyone! I hope you have enjoyed your time in the city of brotherly love and at Bio 2019! I’m Crystal Booth. I’m a Regional Manager with PSC Biotech Corporation. Today, I’ll be discussing our company and our capabilities on becoming your life science solutions partner.
- #3 PSC is globally recognized. We have highly skilled experts based around the world in strategic locations to provide the best service possible to our clients. Our current global network helps us to meet current and future trends in the industry so we are always ahead of the game. We can easily help global clients stay compliant with regulations in different parts of the world.
- #4 We have clients from all over the world; many of whom you may recognize. No project is too big or too small. At PSC, we are there when our clients need us. We can help you meet your goals on time and on budget.
- #5 PSC is globally recognized. We have highly skilled experts based around the world in strategic locations to provide the best service possible to our clients. Our current global network helps us to meet current and future trends in the industry so we are always ahead of the game. We can easily help global clients stay compliant with regulations in different parts of the world.
- #6 We have clients from all over the world; many of whom you may recognize. No project is too big or too small. At PSC, we are there when our clients need us. We can help you meet your goals on time and on budget.
- #10 Audit Utopia is another software offered by PSC Software. This software is designed to be the center of the inspection team and is accessible anywhere. It offers a faster and easier way to manage inspections with all the necessary tools in a single platform. Audit Utopia increases visibility to all inspection processes, including the scribes, reporting, and request tracking. The software is user friendly, configurable, secure, and cloud-based. This system increases request response time that will impress the regulators.