Essentials for Medical Devices
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Essentials for Medical Device Manufacturers

 

 

Purpose

Employees identify the essential elements of QSR for beginning work in the medical device industry.

 

Objectives  

1.     State the historical development of QSR regulations.

2.     Explain the role and function of standard operating procedures.

3.     Describe the personal role for contamination control.

4.     Identify the sources of contamination.

5.     List the common QSR documentation practices.

6.     Explain material controls.

7.     State the common practices of production and process controls.

8.     Explain the importance of an adequate, appropriate, and sufficient building design.

9.     State the requirements of equipment design and construction.

10.   List the requirements for building, and equipment cleaning and maintenance.

11.   Explain the role of the quality management system.

12.   Explain the role of the laboratory.

 

About the Class

1.     This class uses group-facilitated discussion, multi-media, problem solving activities and facilitated instruction to develop a solid understanding of QSRs.

2.     The optional final exam is approximately 25 questions.

3.     Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.

4.     This class can accommodate up to 25 people.

5.     Duration: 16 hours.

Topics

 

Introduction

1.   Activity: Heard on the Street

 

Past, Present, and Future

1.   Definitions

2.   Perspectives 1900-1962

3.   From 1962 to the present

4.   Into the new millennium

 

Legal Issues

1.   Types of FDA investigations

2.   Investigation documentation

3.   Basic inspection behavior

4.   Enforcement

5.   Errors and consequences

 

Personnel Responsibilities

1.   Personnel

2.   Management

3.   Organization and personnel

4.   Training

5.   Consultants and contractors  

6.   Activity: Staff training activity

Standard Operating Procedures

1.   QA responsibility

2.   Writing, formatting and guidelines

3.   Revisions and approval

4.   Review frequency  

5.   Activity: Writing and Auditing Procedures

Contamination

1.   Sources of contamination

2.   Personal methods of contamination control

3.   Penicillin controls  

Personal hygiene

1.   Rest rooms and hand washing

2.   Clothing to be worn

3.   Clean room activities

Cleaning

1.   Requirements

2.   Types of cleaning

3.   Refuse and trash

 

Documentation

1.   Completion, checking, and correcting

2.   Error descriptions

3.   Non-compliant practices

4.   Fraud and falsification policy

5.   Activity: Documentation Exercise or Documentation Review

 

Materials

1.   Supplier qualification

2.   Material specifications, controls and identification

3.   Sampling

4.   Receiving  materials

5.   Labels and labeling

6.   Non-conforming materials 

7.   Activity: Design A Medical Device

 

Process Control

1.     Identity, strength, quality, and purity

2.     Deviations

3.     Weighing of materials

4.     Charge-in of active ingredients

5.     Amount of active ingredient

6.     Calculation of yield and values

7.     Identification

8.     Processing controls

9.     Statistical, random, or representative

10.   Finished product and in process testing

11.   Time limitations on production

12.   On line testing

13.   Microbiological contamination control

14.   Reprocessing

15.   Documentation  

16.   Activity: Inspection Detection

 

Buildings and Facilities

1.     Design and construction features

2.     Sufficient space defined

3.     Product, equipment, material flow

4.     Designated and defined spaces with examples

5.     Environmental rationale

6.     Methods and parameters

7.     Demonstrated control

8.     Penicillin contamination

9.     Lighting

10.   Air systems

11.   Water

12.   Facility alarms

13.   Waste

14.   Housekeeping

15.   Activity: Facility Design

 

Equipment

1.     Appropriate and suitable

2.     Equipment selection

3.     Blue prints of process

4.     Control devices

5.     Equipment construction materials

6.     Lubricants

7.     Filters design and specifications

8.     HEPA Filters

9.     Procedures and training

10.   Levels of cleaning

11.   Equipment cleaning logs

12.   Work orders and repair orders

13.   Log requirements and exceptions

14.   Activity: Dream Car

 

Validation

1.     Life Cycle

2.     DoE

3.     Qualification

4.     Activity: Validate the Dream Car

Calibration

1.   Key elements

2.   Measurement frequency

3.   Timing, standards, and procedure

4.   Logs for due dates

5.   Consultants and outside firms

6.   Out of calibration responsibilities

7.   Out of service

8.   Calibration documentation

 

Laboratory

1.   Subpart I - Laboratory controls

2.   Establishes control mechanisms

3.   Testing and release for distribution

4.   Certificate of analysis

5.   When an OOS Occurs

6.   Average laboratory results

7.   Laboratory investigations

8.   Procedural requirements

9.   Recent citations

10. Stability chamber

11. Determining expiration date

12. Accelerated stability

13. Reconstitution

14. Procedural requirements

15. Retention times

 

Quality Management System

1.   Purpose

2.   Responsibilities

3.   Incoming materials

4.   Materials inspection

5.   Materials testing

6.   Label specification

7.   Control of labeling

8.   Non-conforming materials definitions     

9.   Documentation review

10. Non-conforming materials

11. Standard operating procedures

12. Process control records

13. Document review

14. Signature logs

15. Deviation from standards

16. Device master record

17. Device history record

18. Quality system record

19. All compliant records

20. Reportable complaint reports

21. Non-conformances and deviations

22. Internal audits

23. Activity: Audit Team

24. Supplier qualification

25. Outsourcing

26. Outsourcing checklist

27. Investigations and reviews

28. Structure of a problem and investigation

29. Investigations include

30. Returned product investigations

31. Complaint investigations

32. Complaints

33. Complaint procedures

34. Complaint files

35. Requirements for complaint investigations

36. Purpose

37. Recall strategy

38. Depth of a recall

39. Product recall classifications

40. Corrective and preventive actions

41. Management involvement

 

Wrap Up

Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.

 

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

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