pharm-fda-995x60 pharm-fda-995x60

FEATURED ARTICLES

  • "Every 483 Observation Has A Training Component"
    "Every 483 Observation Has A Training Component"

    “Every 483 observation has a training component.” Truer words have never been spoken—I only wish it was me who said them. An FDA inspector I heard at a conference almost 15 years ago made this statement, and it forever changed how I look at 483 observations. I’ll admit up front that I have a bias towards training—after all, it’s what I do.  Others don’t necessarily share that bias, being that often training isn’t done well, isn’t timely or effective, isn’t always meaningful. I’ve heard the arguments and can even agree with some of them. But let’s set that aside for now and look at what the inspector meant.

More Featured Articles

WHITE PAPERS & CASE STUDIES

  • Exceeding GMP Of Medical Devices At Each Step In The Production Continuum

    Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.

  • 3 Tips For Safe, Secure Healthcare Shipping
    3 Tips For Safe, Secure Healthcare Shipping

    All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical

  • Improving Quality Processes For Medical Device Development And Manufacturing

    Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.

  • Clinical Trial Logistics In Africa: Ensuring Quality, Compliance And Control

    Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier

  • Selecting, Implementing, And Using FDA Compliance Software Solutions

    We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”

  • How To Survive An FDA Audit
    How To Survive An FDA Audit

    Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records and conducting audits more frequently – up from .06 to .09 per year, according to Bloomberg News. By Paul Dupont, Ropack

More White Papers & Case Studies

PRODUCTS & SERVICES

EZ BioPac™: Powder Transfer Process

EZ BioPac™: Powder Transfer Process

Advanced Powder Transfer for Media and Buffer preparation and Solids additions.

Regulatory Services

Regulatory Services

If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

Regulatory

Regulatory

JHP Pharmaceuticals has an experienced in-house Regulatory Affairs department capable of assisting you with Clinical Trial Applications, New Drug Submissions, and Supplements.

Adverse Event Reporting, Safety and Compliance Software

Adverse Event Reporting, Safety and Compliance Software

Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.

LF-S BenchTop Single-Head Leak Testing Machine

LF-S BenchTop Single-Head Leak Testing Machine

The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process on one Container at a time by means of a Testing Chamber under Vacuum or Pressure.

Drug Safety Issue Tracking Software

Drug Safety Issue Tracking Software

Monitoring and tracking the efficiency and accuracy of organizations’ drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny.
Drug Safety Software Adverse Event Reporting

Drug Safety Software Adverse Event Reporting

TrackWise by Sparta Systems’ Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure.
Drug Safety Audits Software

Drug Safety Audits Software

Without a means to track and schedule, drug safety audits tend to be performed on an irregular basis, typically resulting in disconnected audits with recommendations that not followed up on.
More Products & Services
Newsletter Signup
Newsletter Signup
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.