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ALKU Quality Series: The Importance Of Hiring a Contract Project Manager For Quality Compliance Initiatives!

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Looking to hire for a quality or compliance initiative? Think you have your team of consultants complete? Creating a well versed team of consultants can be a difficult task, but one thing you must always consider when crafting a team is hiring a project manager. Hiring a Project Manager Can Provide Your Company With: Structure… Read more »

ALKU QUALITY SERIES: WHY YOU SHOULD CONSIDER ALKU QUALITY FOR YOUR NEXT FDA COMPLIANCE, REMEDIATION OR STAFF AUGMENTATION INITIATIVE.

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ALKU Quality is a highly specialized consulting firm that focuses on FDA compliance, remediation and other staff augmentation initiatives for the Medical Device, Diagnostics, Pharmaceutical and Biotechnology industries. Our Clients Choose Us Because: ALKU Quality has an extensive network of niche specific consultants located across the U.S. to fill Quality, Validation, Project Management and Regulatory… Read more »

ALKU Quality Series: Outsourcing Your Interview Process

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Are you a hiring manager of a Medical Device, Pharmaceutical or Biotechnology company looking for a niche specific consultant to fill a project need? Do not have the time to go through the interview process yourself? Let ALKU Quality help. On average a client can spend up to 3 hours interviewing a potential consultant for… Read more »

How are you running your Risk Assessment? Hear from Global Director of Engineering, Russ Pizzuto, about proper Risk Management efforts throughout the remediation process!

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When going through the remediation process and dealing with Risk Assessment, the first step to success is preparation. One must start with historical data and complete Risk Analysis. Then follows the field use data, database searches, new design concept and clinical studies. In the “Tips To A Successful Remediation” webinar, Russ Pizzuto gives some insight… Read more »

Don’t “Ostrich-ize” yourself! Hear from Stephanie Skipper, principle consultant, about the importance of participation in the root analysis during the remediation process.

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A common mistake often made during the remediation process is the failure to participate in root analysis. During this process, external “independent” audits are relied upon exclusively. According to Stephanie, many people believe that a third party observation is unbiased and is therefore more trustworthy or valuable, which is not necessarily the case. Internal personnel… Read more »