Quality compliance and excellence ppt....

Quality compliance and excellence ppt

1. Quality Compliance & Excellence Global Experts in Quality Management system Implementation, GxP Auditing and GxP compliance https://qce.co.in

2. Our Vision The aim of QCE is to provide best customer services with compliance, ethical values, Integrity and in committed time frame to achieve the desired Goals. https://qce.co.in

3. Who We Are Quality, Compliance and Excellence (QCE) is a complete solution provider in the field of: Pharmaceuticals, Medical Devices and Food Sector. The QCE team comprises of professionals having rich and extensive experience in Quality Assurance, Regulatory Affairs, GxP Auditing, QMS Implementation, Validations, Qualifications, Quality Compliance and Clinical Research. https://qce.co.in

4. Who We Are https://qce.co.in

5. OUR TEAM QCE team comprises of highly experienced and qualified professionals. Having a team of highly qualified professionals and Lead auditors who are mainly based in UK, EU, India, USA, China and Brazil . QCE understands the importance of confidentiality and treats the information shared by our clients with complete prudence. Compliance and Integrity are our core Principles. https://qce.co.in

6. What We Do? We offer our services in the field of: GxP Audits ManagementAnd Consultation services Management of complete supplier portfolio for customer organizations. Management of self inspection program for customer organizations. Gap Assessment against Regulatory requirements such as USFDA, EUGMP, PICS, TGA, Eurasia etc. GMP Trainings. Green Field project consultations and monitoring. https://qce.co.in

7. What We Do? Cont. Validation services. Computer System Validation (CSV) Services. GMP audit preparation for USFDA, MHRA, PIC/S, ANVISA, WHO-GMP etc. Regulatory support for Dossier Preparation and submission. Calibration services from ISO 17025 accredited lab. Procurement services for QC instruments and Production Equipments/Instruments. Support in implementation of Paperless Documentation (eBMR, eQMS and LIMS etc.). Recruitment and Career Counseling Services. https://qce.co.in

8. 1) : GxP Audits Management And Consultation services Auditing of API manufacturing sites. Auditing of Excipient manufacturing sites. Auditing of Packaging Material manufacturing sites. Auditing of Gamma and ETO sterilization facilities. Auditing of formulation facilities (Injectables, Ophthalmic, Liquids and Orals etc.). Preparation, surveillance audits and consultation services for ISO 9001, 14001, 45001, 22000, 17025 and 13485. Auditing of contract Development organizations, CRO, CTL and CMO. https://qce.co.in

9. 2) Management of complete supplier portfolio for customer organizations: Support in preparation of supplier qualification program. Support in preparation of annual audit schedules. Execution of supplier audits as per schedule. Support in preparation of supplier risk assessments. Support in Annual evaluation of suppliers and regulatory action monitoring. Support in performance of supplier investigation/for cause audits. https://qce.co.in

10. 3) Management of self inspection program for client/customer organizations : Support in preparation of annual self inspection plans. Training of Internal auditors. Execution of internal audits as per defined schedules. Submission of internal audit reports and CAPA support. Corrective action & Preventive actions (CAPA) effectiveness check. Monitoring of continuous improvements in Quality Management system. Support and Monitoring of Management Quality Reviews. https://qce.co.in

11. 4) Gap Assessment against Regulatory requirements such as USFDA, EUGMP, PICS , TGA, Eurasia: Assessment of existing Quality Systems against the Regulatory requirements. Evaluation of Gaps. CAPA proposals and Monitoring. CAPA implementations and Monitoring. Effectiveness checks. Assessments of manufacturing sites for Regulatory Audits. https://qce.co.in

12. 5) GMP Trainings : Support in preparation of GMP Training schedules. Train the Trainer Trainings. Execution of GMP trainings as per regulatory requirements. SME (Subject Matter Expert) development trainings. Data Integrity Trainings. Internal auditor Trainings. Good manufacturing Practices Trainings. Good Laboratory Practices Trainings. Good Documentation Practices Trainings. https://qce.co.in

13. 6) Green Field project consultations: Consultation support in green field projects to comply with various regulatory requirements: CDSCO WHO EUGMP USFDA UKMHRA etc. Support in Qualification and validation activities(URS/FAT/SAT/IQ/OQ/). https://qce.co.in

14. 7) Validation services: Support in validation and qualification services of HVAC systems and clean room. Support in validation and qualification services of utilities such water systems, nitrogen systems, air compressors etc. Support in validations of autoclaves, Dry Heat sterilizers and ETO sterilizers. Support in review of Qualification, process validation/Revalidation and Equipment Qualification/Requalification Protocols/reports. Support for transport validation. Support for Storage area temperature mapping services. https://qce.co.in

15. 8) Computer System Validation (CSV) Services: Assessment of existing systems for CSV requirements. Support in development of plans for CSV. Execution of CSV as per approved plans. Verifications. Audits of IT systems. https://qce.co.in

16. 9) GMP audit preparation for USFDA, EUGMP , UKMHRA, PIC/S, ANVISA, WHO-GMP: GMP gap assessment and remediation of Quality systems, Manufacturing, laboratory and Engineering systems. Development of Document Management System. Development of entire Quality and GMP System. Support for Equipment, Utility and Facility Qualification. Support for process, analytical and cleaning validation. Support for risk assessment of the system and facility. https://qce.co.in

17. 10) Regulatory support for Dossier Preparation and submission: Preparation and submission of Dossiers for ROW markets. Preparation and submission of Dossiers for US markets. Preparation and submission of Dossiers for EU markets. Management of communication with Regulatory bodies on behalf of customer organization. Management of Licenses with CDSCO. Handling of Regulatory Queries. https://qce.co.in

18. 11) Calibration services from ISO 17025 accredited lab: Calibration services for all kind of instruments from ISO 17025 accredited lab. Auditing of calibration laboratories. Support for management of calibration schedules. Management of complete calibration cycle of instruments on behalf of customer organization. https://qce.co.in

19. 12) Procurement services for QC instruments and Production Equipments/Instruments : Provide support in purchase of Laboratory glassware. Provide support in procurement of various equipments/instruments required for production, Utility and QC lab. Provide support in set up of QC Labs. Provide support in set up of Microbiology Labs. https://qce.co.in

20. 13) Support in implementation of Paperless Documentation (eBMR, eQMS and LIMS etc.) : Assessments of client requirements w.r.t. electronic records/documents. Preparation of plans as per client need. Implementation of electronic systems in compliance with 21 CFR and EUGMP Requirements. Verification of electronic systems. Audits of electronic systems. https://qce.co.in

21. 14) Recruitment and Career Counseling Services : Recruitment support for various technical/Non Technical positions. Counseling support to university students for their selection and growth in various streams in pharmaceutical industry. Counseling support to industry professionals for their selection and growth in various streams in pharmaceutical industry. https://qce.co.in

22. How it works: Client/customer need support for any of above services, Do contact us by any means (Email, Phone, Whatsapp) with your requirements. Once we receive your request, QCE will evaluate the requirements thoroughly. QCE will connect with client for more details and discussions if needed. QCE will share the proposal and outcome of project to client. Client will review the proposal and provide their comments if need any changes or provide go ahead for the project. QCE will initiate the project and complete as per agreed proposal. https://qce.co.in

23. Our Precious customers: https://qce.co.in

24. Contact Us: You can reach us by any of the below means and we will be very happy to help you: Our website: https://qce.co.in Head Office: Quality, Compliance & Excellence #194, Mohin Dosarka, Ward No.11, Hamirpur, HP-177001 Mobile: [phone] (Whatsapp ) Email: [email protected] [email protected] [email protected] Branch Office: Quality, Compliance & Excellence #04, HPSEB Colony, Nalagarh, HP-174101 Mobile: [phone] (Whatsapp ) Email: [email protected] [email protected] [email protected] https://qce.co.in

25. Thank You https://qce.co.in