1. This class cannot be shared or copied without the written permission of PracticeWorks Systems, LLC.

2. MASTERWORKS Training

3. CHRa1.100.RC1.2 PracticeWorks Quality System Overview

4. Objectives After completing this class you should be able to:

5. Objectives After completing this class you should be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA)

6. Objectives After completing this class you should be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA) Define a Quality System

7. Objectives After completing this class you should be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA) Define a Quality System Locate the Quality Policy on the intranet site

8. Objectives After completing this class you should be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA) Define a Quality System Locate the Quality Policy on the intranet site Understand your role in maintaining an effective system for Quality

9. Overview of Quality Quality What is Quality?

10. Overview of Quality Quality What is Quality? Sales SupportRetirement

11. Overview of Quality Quality Value What is Quality?

12. Overview of Quality QualityDelivery Value What is Quality?

13. Overview of Quality Quality Support Delivery Value What is Quality?

14. Overview of Quality Quality Support Delivery Value Reliability What is Quality?

15. Overview of Quality Quality Support DeliverySafety Value Reliability What is Quality?

16. PracticeWorks and the FDA

17. White House Department of Health and Human Services Food & Drug Administration BiologicsDrugsFood Medical/Dental Devices Cosmetics Radiation Emitting Devices PracticeWorks and the FDA FDA Responsibilities

18. PracticeWorks and the FDA Regulated facilities must: Comply with Federal Law – Quality System Regulation (QSR) Clear medical and dental devices through the FDA before bringing them to market Maintain the safety and effectiveness of our products Government Requirements

19. PracticeWorks and the FDA Quality Policy Outline quality goals FDA Mandates

20. PracticeWorks and the FDA Quality Policy Outline quality goals Quality System Attain quality goals Manage quality issues Measure quality Ensure public safety FDA Mandates

21. PracticeWorks and the FDA Quality Policy Outline quality goals Quality System Attain quality goals Manage quality issues Measure quality Ensure public safety Quality System Documentation Maintain quality records FDA Mandates

22. PracticeWorks and the FDA Inspections are used to police adherence to the QSR Inspectors must have access to the facility and to certain records PracticeWorks has been regularly inspected Inspectors look for non-compliance FDA Inspections

23. PracticeWorks and the FDA Inspections are used to police adherence to the QSR Inspectors must have access to the facility and to certain records Inspectors look for non-compliance Failure to comply could result in: – FDA warning letters – Product recalls – Federal injunctions – Federal charges against company individuals FDA Inspections

24. PracticeWorks and the FDA Business processes Impact safety and effectiveness of products Business activities or procedures Impact product quality FDA Care About...

25. PracticeWorks and the FDA Warehouses The FDA Care About...

26. Warehouses Customer Service departments PracticeWorks and the FDA The FDA Care About...

27. Warehouses Customer Service departments Purchasing procedures PracticeWorks and the FDA The FDA Care About...

28. Warehouses Customer Service departments Purchasing procedures Sales personnel PracticeWorks and the FDA The FDA Care About...

29. Consider this … Why does the FDA care about our technical support calls?

30. Answer Why does the FDA care about our technical support calls? Technical support call representatives must professionally handle and document customer complaints and address potential problems that place patients at risk in a timely and responsible manner.

31. Let’s Review Clear certain dental devices / dental software with the FDA Maintain a Quality System – Quality policy – Documentation FDA inspections FDA examines various business functions PracticeWorks and the FDA

32. Defining a Quality System

33. Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

34. Defining a Quality System Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

35. Defining a Quality System Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

36. Defining a Quality System Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

37. Defining a Quality System Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

38. Defining a Quality System Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

39. Defining a Quality System Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

40. Defining a Quality System Quality System Training & Development Quality Manual Tools & Systems Policies Quality System Components

41. Defining a Quality System Predictable and Verifiable Outcomes Quality System Purpose

42. Defining a Quality System Predictable and Verifiable Outcomes Continuous Improvement Quality System Purpose

43. Defining a Quality System Predictable and Verifiable Outcomes Continuous Improvement Reality Matches SOPs Quality System Purpose

44. Defining a Quality System Complaint Handling Corrective & Preventive Action Design Controls Document Controls Handling, Storage, Distribution & Installation Identification & Traceability Quality Manual Elements

45. Defining a Quality System Complaint Handling Corrective & Preventive Action Design Controls Document Controls Handling, Storage, Distribution & Installation Identification & Traceability Labeling & Packaging Management Personnel & Training Process Validation Purchasing Controls Quality Records Servicing Quality Manual Elements

46. Defining a Quality System Complaint Handling Corrective & Preventive Action Design Controls Document Controls Handling, Storage, Distribution & Installation Identification & Traceability Labeling & Packaging Management Personnel & Training Process Validation Purchasing Controls Quality Records Servicing Business functions affected: Distribution Human Resources Implementations Marketing Purchasing Research & Development Sales Servicing Support Quality Manual Elements

47. Let’s Review Quality System Quality manual Training and development Business tools Policies Quality System helps to prevent defects and errors Defining a Quality System

48. Locating the Quality Policy

49. “PracticeWorks is committed to delivering high quality products, services and solutions that meet our customers’ needs and regulatory requirements. This is accomplished through the maintenance of an effective quality management system.”

50. Provide reliable, robust products and services that meet customer needs. Effectively maintain and consistently execute our quality system processes. Maintain regulatory compliance. Locating the Quality Policy

51. PLACEHOLDER FOR GUIDED SIMULATION. Locating the Quality Policy

52. Let’s Review Locating the Quality Policy

53. Understanding Your Role in Maintaining an Effective System for Quality

54. Maintaining an Effective System for Quality Quality Assurance Testing Customer Surveys High Quality Products & Services Quality Procedures How Do We Achieve Our Quality Goals?

55. Operating within a Quality System means: Employees utilize defined business processes and procedures What Does It Mean To Me? Maintaining an Effective System for Quality

56. Operating within a Quality System means: Employees utilize defined business processes and procedures Employees are responsible for improving quality and eliminating errors or defects What Does It Mean To Me? Maintaining an Effective System for Quality

57. Operating within a Quality System means: Employees utilize defined business processes and procedures Employees are responsible for improving quality and eliminating errors or defects Employees receive training on standard operating procedures What Does It Mean To Me? Maintaining an Effective System for Quality

58. Operating within a Quality System means: Employees utilize defined business processes and procedures Employees are responsible for improving quality and eliminating errors or defects Employees receive training on standard operating procedures Everyone maintains records What Does It Mean To Me? Maintaining an Effective System for Quality

59. Let’s Review The Quality System enables us to: Achieve our quality goals Comply with the FDA Enjoy the business benefits of a well-structured work environment Maintaining and Effective System for Quality

60. Summary You should now be able to:

61. Summary You should now be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA)

62. Summary You should now be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA) Define a Quality System

63. Summary You should now be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA) Define a Quality System Locate the Quality Policy on the intranet site

64. Summary You should now be able to: Explain how PracticeWorks is regulated by the Food and Drug Administration (FDA) Define a Quality System Locate the Quality Policy on the intranet site Understand your role in maintaining an effective system for Quality

65. CHRa1.100.RC1.2 masterworkstraining@practiceworks.com The names of persons and the data reflected in this demonstration are fictitious and are not intended to represent any real individual, event, or condition. Any resemblance or similarity of the names of persons or data reflected in this demonstration to any actual person’s name, any event, or condition is purely coincidental and unintended.

66. ©PracticeWorks Systems, LLC. 2009. MasterWorks is a trademark of Carestream Health, Inc. The Kodak trademark and trade dress are used under license from Kodak.