Training Management Posts

Gain Competitive Advantage through Risk-based Employee Training

Gain Competitive Advantage through Risk-based Employee Training

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

Being competitive takes skill. Remaining competitive takes continuous effort. It’s what every enterprise strives for, so organizations would do well to heed wise words from the father of business management, Peter Drucker: “The only sustainable competitive advantage is an organization’s ability to learn faster than the competition. Your organization may be getting a run for your money, quite literally, by not investing in a solid learning strategy.”

And when it comes to managing a life sciences organization’s product quality and corporate regulatory risk, wiser words have not been spoken. (more…)

Training Management and SCORM: 5 Facts You Need to Know

Training Management and SCORM: 5 Facts You Need to Know

Justin Smith, Manager of Product Management, Pilgrim Quality Solutions

Do you know the facts about SCORM? SCORM stands for Shareable Content Object Reference Model. SCORM is a technical standard, but that doesn’t mean you should dismiss it as something to be handled by your IT staff. If you’re involved in employee training and competency, you should be aware of SCORM and some of its potential benefits to your training management program. (more…)

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

There’s a popular saying: ‘You don’t know what you don’t know.’ No kidding. But nowhere is this truer than in the regulated workplace. When employees aren’t trained, they run the risk of adversely impacting its quality, its compliance, its reputation, even its profits.

That’s why employee training is an essential component of a comprehensive quality management system. In fact, you’re likely to find well-trained employees at the foundation of any successful organization that manufactures safe, dependable, quality products. (more…)

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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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…)

Time For SaaS?

Time For SaaS?

Michael Reynolds

Outsourced Enterprise Compliance and Quality Management  — application and data management in the form of Software as a Service (SaaS) — is a partnership needed more  today than ever, particularly in the increasingly complex regulatory environment that Pharma, Biotech and Medical Device companies find themselves. (more…)

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance. (more…)