Managing Risk with EQMS
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Having the ability to meet the customers requirements, comply with international standards and regulations, and mitigate potential risks is whats on the mind of any QA or RA professional in the life sciences industry. With that said, being able to utilize an Enterprise Quality Management Software (EQMS) ensures that tasks and activities are being accomplished in an efficient and timely manner. Although there are many EMQS platforms on the market place today, there is only one Intelligent EQMS, and that is QualiPro. During this brief webinar, we will provide you with an overview of QualiPro, its structure and capabilities. Also, we will briefly demonstrate how QualiPro is the ONLY EQMS that can truly help with your risk management and compliance challenges.
Managing Risk with EQMS
- 1. E.M.M.A. International Consulting Group Webinar Series Managing Risk with EQMS 息E.M.M.A. International Consulting Group, Inc. 1
- 2. 息E.M.M.A. International Consulting Webinar Overview Enterprise Quality Management Software (EQMS) The purpose of this webinar Managing Risk with EQMS is to discuss the wide-ranging risk management benefits for organizations who convert paper-based QMS to enterprise-wide cloud-based QMS. The ultimate takeaway is that to remain market competitive from regulatory changes to internal communications - now is the time to transition from manual, paper-based systems to seamless, integrated enterprise based QMS. Dont wait until your risk levels become critical transition now.
- 3. 息E.M.M.A. International Consulting About the Presenter: 3 Carmine Jabri President/CEO carmine.jabri@emmainternational.com Office: 248-987-4497 Cell: 419-215-9108 Carmine Jabri, PhD, MSJ, MSQM, MHA is co-founder of E.M.M.A. International Consulting Group, Inc., and serves as its President and CEO. He has more than twenty years of experience implementing, improving and directing Quality Management Systems and Healthcare Operations. Dr. Jabris career includes expertise in the Biotechnology, Pharmaceuticals, and Medical Device industries. He is an internationally sought-after quality systems expert. Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration and a Bachelor of Science in Chemistry.
- 4. 息E.M.M.A. International Consulting About the Moderator: 4 Patrick K. Powell Director, EQMS patrick.powell@emmainternational.com Office: 248-987-4497 Patrick K. Powell, BSME, MTS, MBA is Director of EQMS solutions at E.M.M.A. International Consulting Group, Inc. He has more than twenty years experience in product engineering, product and resource planning, technology leadership, and marketing. Mr. Powells career includes expertise in automotive and medical devices. He holds over 30 US granted patents. Mr. Powell holds a Bachelor of Science in Mechanical Engineering from the University of Akron, a Masters of Theology from the Moody Bible Institute, and an Executive MBA from the University of Michigan.
- 5. 息E.M.M.A. International Consulting Introduction EQMSs (Enterprise Quality Management Software) are no longer the exclusive space of larger companies. With web-based software, small and medium size organizations can cost effectively implement EQMS in a reasonable time frame, reaping the benefits of efficiency, visibility, quality control, and increased profits. Do not wait until (1) You have an issue too large for your paper-based system to manage effectively or (2) Until you start losing contracts to competitors operating more efficiently with an EQMS. This Photo by Unknown Author is licensed under CC BY- SA To keep up with the market trend and remain cost- competitive, an organization needs to be proactive in adopting enterprise level quality management systems.
- 6. 息E.M.M.A. International Consulting 6 The Changing Business Landscape IN LEADERSHIP, YOU HAVE A LOT ON YOUR MIND! WHAT IF AN ENTERPRISE SOFTWARE SOLUTION COULD MAKE REGULATORY IMPLEMENTATION SEAMLESS? WHAT IF AN ENTERPRISE SOLUTION COULD HELP YOU BECOME MORE COMPETITIVE IN THE MARKET? IT CAN! ITS CALLED EQMS EU MDR ISO 9001 COMPETITIO N 21 CFR 820 ISO 13485 SALES TARGETS COMPLIANC E AUDITS GDP R All artwork is unattributed web
- 7. 息E.M.M.A. International Consulting The Existing Process Slow & Largely Paper Based PRODUCT ENGINEERING MANUFACTURING ENGINEERING PRODUCTION TEAM CUSTOMER CONTRACT DESIGN SPECIFICATIONS PRODUCT MANAGEMENT SAYS: Why cant my teams just talk with one another? TEAMS SAY: This is so frustrating! Im constantly hitting another brick wall. EVERYONE SAYS: There has got to be a better way. There is! Its called EQMS. WALL WALL WALL WALL SALES
- 8. 息E.M.M.A. International Consulting 8 TRAINING RISK DOCUMENTATION CAPA AUDITS INDICATORS NON-CONFORMING PRODUCTS CUSTOMERSSUPPLIERS MEETINGS METROLOGY STAKEHOLDER EQM S What does EQMS do? EQMS connects the pieces of your business customers, suppliers, and departments through a seamless, integrated web-based software platform. It provides document sharing, enterprise visibility, and maximizes control over the process of what you do best satisfying your end users. And with QualiPro Web EQMS, the software follows ISO standards requirements, helping you become compliant with each click of the button.
- 9. 息E.M.M.A. International Consulting 9 QualiPro Web EQMS Solution User Interface KPI DASHBOARD CONTINUOUSLY UPDATED LIVE TEAM COMMUNICATION TOOLS & DAILY UPDATES INSTANT, SHAREABLE REPORTS CONNECTED MODULES 1-CLICK DATA ENTRY
- 10. 息E.M.M.A. International Consulting 10 Succeeding at the New Business Landscape WE GOT THIS! EU MDR ISO 9001 COMPETITIO N 21 CFR 820 ISO 13485 SALES TARGETS COMPLIANC E AUDITS GDPR EQM S HIGHER PROFITS! SATISFIED CUSTOMERS EFFECTIVE TEAMS! REGULATIONS MET! INITIATIVES SUCCESSF
- 11. 息E.M.M.A. International Consulting MANAGEMENT SAYS: What teamwork! The walls are down & people are talking. TEAMS SAY: Its never been so easy to document the life-cycle and satisfy the customers. EVERYONE SAYS: Id wish wed implemented EQMS sooner! PRODUCT ENGINEERING MANUFACTURING ENGINEERING PRODUCTION TEAM CUSTOMER CONTRACT DESIGN SPECS PRODUCT SALES PRAISESUPPORT DFM EFFICIENCY GAINS A Renewed, Highly Effective Organization
- 12. 息E.M.M.A. International Consulting Contact Us: 12 Your EQMS Solution Provider EMMA International Consulting Group Farmington Hills, MI: Headquarters 27600 Farmington Rd., Suite 100 Farmington Hills, MI 48334 Phone (248) 987-4497 Clearwater, FL: 28870 US HWY 19 North, Suite 300 Clearwater, FL 33761 Phone (727) 614-8851 York, PA: 320 Busser Road., Suite 200 Emigsville, PA 17318 Phone (717) 429-6875 Lebanon 7TH Floor, Le Mall Building, Dbayeh Highway, Northern Metn, Lebanon
Editor's Notes
- #6: The new EU MDR regulation aims to create a new and improved landscape for the medical devices industry, with the following new guidelines: All medical devices will have to undergo an independent assessment of safety and performance before they can be marketed in the EU There will be greater transparency of information on the benefits for patients, residual risks, and a thorough assessment of the overall risk/benefit ratio will be necessary There will be clearer rules in place to enable standardization and support simpler and less complex trading between EU member states; those that do not comply will be penalized The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium sized manufacturers in this sector The EU MDR will place further responsibilities on Notified Bodies - those independent third parties that perform conformity assessments for medium and high risk devices. The Notified Bodies will be subject to heightened scrutiny from competent authorities and will need to be designated under the EU MDR, with the process of designation coordinated at a European level