1. Neil Sheahan - QP Forum April 2018
Quality Culture
From a company perspective
Neil Sheahan - QP Forum April 2018

2. Imagine…. If you could reduce errors made at your workplace?
Deviations
Investigations
Reports
Headaches
Friday nights.

3. Quality Culture How to get your Company Passionate about Quality
Quality Leadership
Message Credibility
Quality Culture
From a company perspective
Quality Awareness Team.
Enhance Quality Awareness
&
Ownership of Quality
Quality Culture
Employee Engagement

4. Golden Quality Rules
Golden Rules remain visible as part of our Quality Culture
Lunch & Learn
Informal lunch used to communicate what's ‘Current’ in GMP
Quality Leadership
As per ICH Q10, “Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system.”

5. Employee Engagement

6. Quality Awareness Week
Message Credibility
Quality Awareness Week
Patient Talk

7. 2018 Road Map – Quality Awareness
Jan
Data Integrity/Good Documentation Practice
QA Profiles.
Feb
Audits
Reporting
Mar
Contamination Control
Good Hygiene
Apr
Training – GMP Training, Training in GMP Areas
Human Error
May
Self Inspections
Jun
Quality Review
Qualified Person
Jul
Quality Control
Good Laboratory Practices
Aug
Facilities/ Equipment
Maintenance/ logbooks
Sep
Release Procedure for Finished Products
Distribution
Oct
Computerised Systems GMP
Nov
Good Housekeeping
Cleaning and Sanitation
Dec
Material Management
Storage

8. Quality Culture No. Deviations /person/year
1.18/p/yr.
1.10/p/yr.
1.08/p/yr.
0.92/p/yr.
Not about Deviation Avoidance.
Never linked with Quality Culture.

9. From a company perspective
Increase personal responsibility and accountability for everyone involved in producing our pharmaceuticals
Quality Culture
From a company perspective

10. Thank You