• Top 8 Ways to Reach Regulatory Compliance

    8 December, 2016 MasterControl

    Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.

    Full story
  • The Migraine Known as the Supplier Audit — and Some Simple Remedies

    23 February, 2017 Ken Christie, COO, VTS Consultants

    The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However

    Full story
  • Supplier Approval Challenges Under FSMA

    1 March, 2017 Erika Miller, Food Safety Specialist, D.L. Newslow & Associates, Inc.

    As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

    Full story
  • 2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

    2 March, 2017 Marci Crane, Staff Writer, MasterControl

    For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of

    Full story
  • Five Common Issues that could Jeopardize Training Compliance

    9 December, 2014 Cindy Fazzi, Staff Writer

    If your company is regulated, then you know that 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.

    Full story
  • If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

    23 August, 2016 by Marci Crane, Localization Manager, MasterControl, Inc.

    The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

    Full story