Articles

• Therapeutic Dose: The Importance of Design Qualification

  The DQ is a critical, yet often overlooked part of the process of developing and validating any new pharmaceutical PAT process. It is a strategically important time, where process engineers, material scientists and physical chemists can get together to develop meaningful materials characterization standards.

• Prioritizing Goals by Applying Options Thinking

  Applying systematic methods can improve results and increase value, whether on the corporate or on the local operational level.

• Multivariate Calibration: A Science-Based Method - Part 2

  Science-based calibration (SBC) mechanizes the calibration process by removing choices and by forcing the user to substantiate each of the inputs with scientific backup information

• A Year of Uncertainty: Results of Our 2007 Job and Salary Survey

  Most pharmaceutical industry professionals are relatively happy with their careers, but many long for more challenge, training and growth opportunities, according to our survey.

• Protecting Our Human Capital

  Projected increases in M&A activity demand careful risk vs. benefit analysis, and not only on the ledger sheet

• Compliance and Traceability in Drug Manufacturing

  What was once viewed as a “necessary evil” or a cost of doing business is increasingly being seen as a key competitive advantage, although hurdles remain.

• Importation Illusions

  Manufacturers and consumers would bear most of the risks – and the costs – of importation.

• Coping with Phase III Testing

  Like adolescents, compounds in Phase III require nurturing, but a “real world” approach.

• A Compliance and Traceability Toolkit

  A growing number of quality management and compliance packages can help you seize control of processes and documentation, and prepare for FDA audits.

• RFID Is at its Tipping Point in Pharma

  As counterfeiting continues and regulatory pressures increase, pharma companies must act to secure their own supply chains.

• Drug Pedigree Standard Established

• Industry’s Trust and Reputation Eroded by Perception Gap

  Addressing misconceptions, fostering a culture of compliance and patient-focused behavior and refocusing sales and marketing activities can restore and strengthen the industry

• Operations Management: Career Management for the 21st Century

  Business pressures are bringing pharmaceutical companies to a realization that some other industries have had for years: profesionals with operations management skills are vital to the success of the enterprise.