Top 5 Trends in the Pharmaceutical Industry in 2015

If the surge in TV commercials for prescription drugs is an indicator of the economic health of drug companies, then the pharmaceutical industry is indeed going strong. The industry’s advertising spending rose from $3.5 billion in 2012 to $4.5 billion …

5 Tips for Getting Executive Backing for a New or Expanded EQMS

If you and your team are responsible for improving the efficiency and effectiveness of quality and compliance in your organization, sooner or later you are likely to face a challenge—getting the support of executives and other departments in either establishing or expanding an electronic quality management system (EQMS).

Most executives cite the high cost of adopting technology as the main reason they reject plans to buy software or expand system usage. There are many reasons for interdepartmental resistance to system adoption, but the most common is the lack of understanding of the value of quality.

This white paper is based on a MasterControl group discussion that explored the underlying factors behind executive and organizational opposition to an electronic quality system. The participants came from regulated companies that use MasterControl software.

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A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

This eBook dives deep into life science challenges and how leading organizations are approaching them. Specifically, it addresses:

  • How rising world populations and standards of living are increasing spending on healthcare.
  • Pressure of cGMP regulations from FDA and other regulatory bodies.
  • Organizations for approaching quality holistically rather than “as a department”.
  • Real-world examples of leading life science companies’ responses to regulation issues.
  • Benchmark data on how EQMS and MOM applications correlate to improvements in On-Tim Complete Shipments (OTCS), New Production Introduction (NPI), and Products in Compliance (PiC).
  • Recommended actions.

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How Effective Training Management Can Help You Prevent Quality Issues

It’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work. “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring,” said Hunter.

In a regulated environment, training is a means to minimize (if not avoid) human error, a common cause of deviations and nonconformances. It’s no wonder that various standards and regulations, such as the following, require training as an integral part of the quality management system.

  • FDA 21 CFR Part 211.25 for pharmaceutical companies
  • FDA 21 CFR Part 820.25 for medical device manufacturers
  • ISO 9000 2000 for general manufacturers and other businesses
  • ISO 13485 for medical device manufacturers

Request Free!

A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

This eBook dives deep into life science challenges and how leading organizations are approaching them. Specifically, it addresses:

  • How rising world populations and standards of living are increasing spending on healthcare.
  • Pressure of cGMP regulations from FDA and other regulatory bodies.
  • Organizations for approaching quality holistically rather than “as a department”.
  • Real-world examples of leading life science companies’ responses to regulation issues.
  • Benchmark data on how EQMS and MOM applications correlate to improvements in On-Tim Complete Shipments (OTCS), New Production Introduction (NPI), and Products in Compliance (PiC).
  • Recommended actions.

Request Free!

How Effective Training Management Can Help You Prevent Quality Issues

It’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work. “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring,” said Hunter.

In a regulated environment, training is a means to minimize (if not avoid) human error, a common cause of deviations and nonconformances. It’s no wonder that various standards and regulations, such as the following, require training as an integral part of the quality management system.

  • FDA 21 CFR Part 211.25 for pharmaceutical companies
  • FDA 21 CFR Part 820.25 for medical device manufacturers
  • ISO 9000 2000 for general manufacturers and other businesses
  • ISO 13485 for medical device manufacturers

Request Free!

A Guide to Successful Western Blotting

The western blot technique (WB) is a powerful tool to elucidate the complex signaling events that underlie biological processes and disease. This paper highlights critical steps in the western blot protocol and demonstrates how protocol changes can aff…

A Guide to Successful Western Blotting

The western blot technique (WB) is a powerful tool to elucidate the complex signaling events that underlie biological processes and disease. This paper highlights critical steps in the western blot protocol and demonstrates how protocol changes can aff…

PMP News.com Daily eNewsletter

Each day, PMP News.com Daily will deliver breaking news in the pharmaceutical and medical device packaging industry along with general pharmaceutical and medical device industry news to subscribers in a user-friendly, one-click eNewsletter format.Reque…