Quality with Good Intent

Julie Waltz Gerlach, BSN, MPH, RAC

Confessions from the real world.  I worked with a virtual client for many years, submitting

regulatory documentation to regulatory agencies, writing SOPs, and conducting external audits

of their contract research organizations (CRO); clinical vendors, and investigator sites, etc. 

Everything was on track for the investigational product development, until the client received a

Form FDA 483.

What happened?

The client purchased a marketed product taking over a New Drug Application a year earlier and

neglected to submit the quarterly safety reports to the FDA.  FDA came to inspect and noted the


• There is no Quality Plan- (there was a plan but the VP of Quality had not signed- thus no

plan).  This is often one of the FDA's top findings.

• Contractual agreements with Contract Manufacturers were not complete or signed.

• Safety reports had not been submitted within the required timeframe.

• A medical director (safety officer) resigned and there was a lapse of a several days before

a new safety officer was hired to take over the responsibilities.  

In short, the Form FDA 483 contained over 15 observations.   

Regulatory and quality professionals understand quality is key to the development and continuation of drug, medical device, and biologic development and safety. However, if we really explore the topic, does everyone understand it requires being proactive to keep quality measures in place?  Quality professionals can provide a quality oversight for our clients and avoid greater issues in the future. When I work with a client I:

• Explore the topic of clinical and manufacturing quality with the client. 

Although larger clients may have a Quality Operations in place, smaller clients with limited operations may need the additional support and services of virtual or onsite quality


• Review and determine if risk assessments have been conducted to measure the quality health of the client. 

• Help the client understand that a lack of quality oversight and execution equates to more expensive measures and potential safety issues, recall of product(s) over time, loss of key personnel, etc. This also impacts the shortage of drug or devices in the marketplace thus impacting health and safety measures for patients and healthcare providers.

• Assist the client in understanding that updated regulations are focused on data integrity and quality measures that should be in place.   


At Kinexum our Quality professionals teach our clients about the inherent risks and help them take proactive measures so they remain compliant in today's global marketplace, which ultimately protects the patients’ safety and health.