Konyika Nealy Posts

The Role of the Internal Quality Auditor

The Role of the Internal Quality Auditor

Konyika Nealy, Vice President of QA and Validation, Pilgrim Quality Solutions

As an experienced member of your organization you may at some time be called upon to conduct an internal audit. This is a good thing. Internal audits are intended to preempt issues that can arise during a second or third party audit. This type of peer review though, if not managed correctly, can have negative consequences that undermine its value.
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The 5th Incarnation: Proposed Changes to ISO 9001

The 5th Incarnation: Proposed Changes to ISO 9001

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions 

Are radical changes coming? Is this fifth incarnation of ISO 9001 a drastic departure from its predecessor? Will it reshape the world of manufacturing as we know it? Word around the water cooler is “No.” (more…)

Measuring the Success of Training and Competency

Measuring the Success of Training and Competency

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

According to 21 CFR Part 211 Subpart B, Section 211.25 (Personnel Qualifications),

Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice…as they relate to the employee’s functions.

But what does an effective training program look like?  How do you measure success? (more…)

Get with the (Management) Program… for a Change

Get with the (Management) Program… for a Change

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

Social networks, outsourcing, mobile apps, expiring patents, mergers and acquisitions, are but a few landmarks in the last 10 years that have changed the way business is conducted forever.  If nothing else, industries have acknowledged that they must embrace change to remain competitive and protect market share.  As such, regulated industries such as life sciences, must adopt a proactive and systematic method to integrate new technologies and efficiencies while preserving the quality, safety and efficacy of their products and services. (more…)

CAPA Risk Management and ROI

CAPA Risk Management and ROI

Konyika Nealy, Director of Quality Assurance, Pilgrim Quality Solutions

CAPA systems provide a wealth of information regarding the quality of a product or process.  However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line. For instance, it is commonplace for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records, of varying degrees of severity, which are often vetted by issuance order rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process? (more…)