Confidential. For internal Use Only.

1 of 47Course # GQUAL-003158

Part 1: Recognizing Quality Standards

BACKGROUND:

• Our natural inclination is to ignore problems and conflicts

• To be proactive our senses have to be alert

- Our eyes must be open

- Our ears must be listening

• Being alert leads to enhanced Quality

Confidential. For internal Use Only.

2 of 47Course # GQUAL-003158

Being Alert and Quality

ENHANCED QUALITY

• Why Quality matters

• Quality vs Compliance

Confidential. For internal Use Only.

3 of 47Course # GQUAL-003158

If 99.9% is good enough, then….

12 newborns will be given to the wrong parents daily.

2,000,000 documents will be lost by the IRS this year.

2 planes landing at Chicago O’Hare

291 pacemaker operations will be performed incorrectly.

103,260 income tax returns will be processed incorrectly during the year.

20,000 incorrect drug prescriptions will be written this year.

airport will be unsafe every day.

18,322 pieces of mail will be mishandled / hour.

Confidential. For internal Use Only.

4 of 47Course # GQUAL-003158

The “NEW” Baxalta Way of Thinking!

You

Confidential. For internal Use Only.

5 of 47Course # GQUAL-003158

“Do not be afraid to set tough standards and expectations!”

“Expect perfection or you will never achieve it!”

“The Quality of the work that we accept becomes our standard.”

PRESENTED at GMP BY THE SEA CONFERENCE, July 29 - 31, 2013 from…

Proactive Compliance: The Next Generation of Worldwide Regulatory Expectations and Enforcement

Richard Davis, BS, President, Richard Davis and Associates LLC (former Regional Director, FDA)

5 of 39

The “NEW” Baxalta Way of Thinking!

Confidential. For internal Use Only.

6 of 47Course # GQUAL-003158

Inspections

Anticipating an internal or external inspection

“I’ve been preparing for the inspection but did I miss something?”

This is the anticipation that you may feel before an inspection.