All Blog Posts (33)

A Subject Matter Expert (SME) or domain expert is a person who is an expert in a particular area or topic. When faced with the FDA or another regulatory agency, we tend to call on SMEs that are most intimate or familiar with the details of the process or product in question. In some cases, we reach too deeply into the organization to an individual that has comprehensive knowledge of technical/processes, but not effective at explaining this information. Thus, we open the door to unnecessary…

It is indisputable that life science companies, like all other businesses, are struggling to survive in these very rocky economic times. Uncertainty regarding the future of healthcare costs and global financial stability, unpredictability regarding certain FDA positions (e.g., will 510(k) rules be relaxed or not?, how will FDA regulate supplements?, increased/decreased regulatory burden on brand-name drugs?), difficulty in raising capital and resulting fear of hiring additional…

During one of my early inspection experiences with the FDA,  I found myself working with a team who felt they didn’t need a backroom setup to review documents prior to bringing them to the investigator.  Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.



The investigator requested a specific document which was brought into the room. During the review, the investigator asked to speak to the individual…

When was the last time an inspector from the FDA

showed up at your site? While many FDA inspections are scheduled with some

advance notification, there is always a possibility that an inspector from the

Agency could show up at your door any time. Are you prepared?

It is a standard practice to have a Standard

Operating Procedure (SOP) defining what your organization should do when the

FDA (or other government agency) shows up at your site. Some of…

My last blog on design verification and validation triggered a lot of comment and response. In fact, some of you started bringing process validation into the discussions. Related to FDA definitions of terms, 21 CFR 820 defines process validation as:



“(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be…

The best answer is everyone in the organization. From the CEO through the assembly line operators, this is the one document within your quality management system that everyone should use.

The various ISO standards (ISO 9001:2008 and ISO 13485:2007) require a quality manual as part of the documentation system. FDAs’s Quality System (QS) regulation (21 CFR 820) requires each manufacturer establish a quality plan defining the quality practices, resources and activities relevant to the…

I have had many conversations with individuals related to the many software tools currently available on the market these days. Inevitably, the discussion turns to the need to “customize” the tool for specific use, and the need for validation.

Customized software tools require the manufacturer or the customer to modify the source code of the product to meet a specific intended use. The software or product is designed to be specific to the needs of the individual…

 Document control is still one of the most commons areas of non-conformance in audits and inspections. Analysis of these non-conformances identifies the failure is most often the result of non-compliance to the procedure, rather than noncompliance to the regulation or standard. Let’s look at some of the practices in industry that contribute to these types of issues.



Sometimes, SOPs are written very explicitly in an attempt to error proof them for the employee. As employees become…

A

strong risk management program is one of the cornerstones for an effective quality management system. Does your risk management program extend deep enough into the processes to benefit your organization? Three main areas where risk management can be of great benefit are product safety, process control and

project management.



The ISO 14971:2007 Medical devices – Application of risk management to medical devices document defines requirements to…

CAPA stands for Corrective Action Preventive Action and is the heart of a strong quality system. It usually is the starting point for most FDA inspections and other quality system audits. There are numerous feeder systems into the CAPA system. A few examples include:



 ·      Complaint management system

 ·      Adverse Event reporting 

 ·      Acceptance test failures 

 ·      Raw material supply failures/issues

 ·      Nonconforming product

 ·      Field service…

A strong internal audit program can provide executive management with an overall view of the health of the quality system. In my opinion, it is one of the most critical subsystems in the quality system. When effective audits are performed AND meaningful metrics are generated, quality system strengths and gaps become more evident to executive management.  

So how do you determine if your internal audit program is effective? It’s more than just generating non- conformances and…

The basic concept of Good Manufacturing Practice (GMP) is based on two key quality principles:

• Processes and procedures are designed and validated to assure products are manufactured to meet specification and perform as expected for the customer.

• Employees are trained on processes, follow procedures and empowered to stop the line whenever there is a problem or failure.



While GMP is a requirement in regulated industries, the basic principles are applicable in…

It is rare to be writing about (literally) the first person you met in industry-almost 20 years ago, and he is STILL serving in the role as a teacher, author and mentor.

Back in the early 90's, I owned the Institute of Validation Technology, and was hosting my first industry conference on "Packaging Validation." I was fortunate enough to meet John Stromp, then working for SmithKline Beecham. I learned that he had a background as a teacher and instructional designer, and I asked him to…

Before our GLP Training workshops we conducted recently in California, I had a number of concerns, including meeting our attendees information expectations. Our instructor, Celeste Rose, had developed a number of "real-life" group application team exercises that we were trying for the first time. How would it all work out?

We never expected to have such a fun time in the process...

Attendees Learned and Laughed

Attendees developed a camaraderie among…