Recognising & Overcoming your Quality &                  Regulatory Challenges – Internally & Externally                  ...
Key Points                                                             Internal & external quality                       ...
Why do we need compliance?                                                             Important for patient safety      ...
What happens if you don’t comply?                                                                  Legal consequences    ...
External Regulatory Challenges                                                                  Medical Devices Directive...
What’s Changing?                           Existing legislation                                                           ...
Internal Challenges                                                             Inefficient compliance activity          ...
Business Challenges - Life Sciences                                                                  Internal & External ...
Other sectors - Aviation                                                             Safety and quality compliance       ...
Food & Drink, Manufacturing                                                             Protecting reputation            ...
How do you manage compliance?                                                             Manual paper based system?     ...
Practical Issues                                                                  Ownership                              ...
Overcoming the Challenges                                                             Ownership & Responsibility         ...
A Possible Solution                                                             An effective, reliable and               ...
Business Example         A short video from Scottish Pharmaceutical         services company, Symbiosis, discussing the   ...
How can it help?                                                             Design Control - Life Cycle                 ...
Benefits                                                             Help achieve your Regulatory                        ...
Benefits cont’d                                                             Effective notification                       ...
Regulatory Compliance – Top Tips                                                             Effective People Management ...
Thank you for listening!                                                            Visit-                                ...
Upcoming SlideShare
Loading in …5
×

Overcoming Internal & External Regulatory & Quality Challenges

1,003 views

Published on

Presentation illustrating both the internal and external quality and compliance challenges a company may face when trying to achieve and maintain regulatory compliance. The regulations and standards mentioned are specific to the medical devices sector, however, the majority of the content should be applicable to a number of industry sectors.

Published in: Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
1,003
On SlideShare
0
From Embeds
0
Number of Embeds
3
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Overcoming Internal & External Regulatory & Quality Challenges

  1. 1. Recognising & Overcoming your Quality & Regulatory Challenges – Internally & Externally Lorna Elmslie - Marketing Manager, Healthcare & Life Sciences E: lornae@gaelquality.comQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  2. 2. Key Points  Internal & external quality challenges  Business challenges in other sectors  Best Practice in overcoming these challenges  Benefits of a possible solution  Top Tips for managing your compliance activitiesQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  3. 3. Why do we need compliance?  Important for patient safety  For business reasons  Human and business consequences to getting it wrong  To ensure performance is sufficientQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  4. 4. What happens if you don’t comply?  Legal consequences  Fines  Staff Time  Commercial RevenueQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  5. 5. External Regulatory Challenges  Medical Devices Directives  ISO 13485  ISO 14971  CE Mark  FDA 21 CFR 820 More regulators, more expectations - more chaos!Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  6. 6. What’s Changing? Existing legislation Future legislation Medical devices directive Medical devices regulation Active implantable medical devices directive In vitro diagnostic medical In vitro diagnostic medical devices directive devices regulation Source – MHRA websiteQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  7. 7. Internal Challenges  Inefficient compliance activity processes  Attitudes to Quality/Compliance  Staff ‘buy-in’  Production v’s Quality Mentality  Setting an appropriate standard of Quality  Access to financeQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  8. 8. Business Challenges - Life Sciences  Internal & External Audits  Managing Customer Complaints  Incident Reporting  Customer needs ‘v’ Regulatory requirementsQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  9. 9. Other sectors - Aviation  Safety and quality compliance  Disparate, disconnected systems  Regulatory compliance  Mandated to comply with international safety standards & regulationsQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  10. 10. Food & Drink, Manufacturing  Protecting reputation  Embracing a quality/safety culture  Silos of information  Admin burden  Reactive rather than proactive  No analysis of issues  No traceability or visibilityQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  11. 11. How do you manage compliance?  Manual paper based system?  Excel spreadsheets?  Inhouse/’home grown’ system?Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  12. 12. Practical Issues  Ownership  Visibility  Access  TrainingQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  13. 13. Overcoming the Challenges  Ownership & Responsibility  Benchmarking to the highest standard and educate  Understanding where flexibility is required  Risk Assessment/Benefits/Viability  Team Effort  Get your compliance activities organised!Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  14. 14. A Possible Solution  An effective, reliable and appropriate Quality Management System (QMS)Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  15. 15. Business Example A short video from Scottish Pharmaceutical services company, Symbiosis, discussing the challenges they faced as a start up and how they overcame them. http://www.youtube.com/watch?v=fcK60nJmaiUQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  16. 16. How can it help?  Design Control - Life Cycle  CAPA  Internal Audits  Complaints Management  Post-Market Surveillance and Vigilance  Supplier Evaluation  TrainingQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  17. 17. Benefits  Help achieve your Regulatory objectives  Accountability  Analytical intelligence  Encouragement to appropriate peopleQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  18. 18. Benefits cont’d  Effective notification  Reduction in risk  Address Uncertainty  Support correct Decision making  Drive Performance ImprovementQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  19. 19. Regulatory Compliance – Top Tips  Effective People Management  Keep up with Regulatory Changes  Plan and manage your Regulatory inspection well  Collaboration is keyQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  20. 20. Thank you for listening! Visit- GaelQuality.com Email- lornae@gaelquality.com Follow on Twitter- @GaelLornaEQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.

×