FDA has granted precious few applications for waiver since their CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, has discouraged companies from bringing new innovations to this critical public health sector.
With the CLIA Waiver guidance appearing to be so prescriptive, why has denial dominated the review outcome?
By attending this this two-day workshop conference on Clinical Laboratory Improvement Amendments (CLIA) attendees will:
Note: Use coupon code 232082 and get 10% off on registration.
This FDA inspection training webinar provides practical advice on the FDA...
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Understand the 10-step risk based approach to validation, explore methods to...
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This CAPA program provides the framework for avoiding an FDA warning letter and...
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This training will discuss regulatory requirements for monitoring of...
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This course will offer guidance for those employing young personnel in their...
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Course Description: Did you know? Those taxpayers with...
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Course Description: This seminar will cover auditing human resources practices...
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This webinar will provide the principles for writing an effective audit report....
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Reputational risk is receiving a tremendous amount of focus. Organizations need...
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Aims: A 2-day intensive course on business continuity and scenario planning...
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This webinar will discuss the challenges and opportunities involved in...
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Course Description: Gain in-depth knowledge on Harmonized Tariff Schedules and...
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Course Description: FDA inspection and oversight of quality control (QC)...
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Course Description: Increasing demands on the audit profession by regulators,...
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This webinar will explain key components of a fraud risk assessment and...
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This training on using certified reference material in analytical laboratories...
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This course will help you understand how to insulate your company from legal...
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Form W-2 is one of the most important documents that payroll departments must...
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This training session on managing an FDA high-risk food inspection will outline...
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This 90 minute California wage and hour compliance training will help you...
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This training on Bank Secrecy Act regulations will highlight BSA compliance and...
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Attend this webinar to understand the process of a letter of credit and how to...
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This webinar will cover both Family and Medical leave Act (FMLA) and the...
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This project management training for FDA regulated companies will show how you...
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Course Description: This highly interactive course is designed to provide...
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Learn as a manager, how to detect harassment early and manage proactively. Why...
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Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance...
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Skilled auditors require a method that aligns what they experienced during the...
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This webinar on clinical study design will explore the differences among...
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Aims This is an intensive course on Operational Risk Management & Mitigation...
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Course Description: This course will present an overview of necessary actions...
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Determining the ability of an entity to generate cash flow is essential...
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This ICH Q10 training /webinar will discuss the evolution and interpretation of...
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This 90-minute webinar will guide you through the critical steps in ensuring...
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This FDA documentation webinar will explain the regulatory expectations for,...
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Course Description: The Institute of Internal Auditors defines Risk Based...
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Course Description: Federal regulation of the advertising and promotion of...
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Course Description: Manufacturing an investigational product for the initial...
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This webinar will discuss the risks and costs of data breaches. Participants...
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Understand the steps of a extractables / leachables study, get knowledge about...
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This webinar will explain how to design and administer monitoring and auditing...
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This webinar will highlight the techniques and best practices that can be used...
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This training session will define why HR audits are a vital part of a...
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This training session will instruct attendees on the Tobacco Control Act’s...
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Course Description: Bribery can often damage your business and your...
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Course Description: Human resource administration is complex today. Much...
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Course Description: Naturally, getting a project to deliver on time, within...
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Course Description: Analytical instruments should be qualified and systems...
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Course Description: In-vitro Diagnostics (IVD) products...
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Course Description: With FDA citing inadequate change control constantly in...
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Aims Recently, a series of headline-grabbing operational risk incidents at...
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Aims This is an intensive course on Operational Risk Management & Mitigation...
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Aims: A 2-day intensive course on business continuity and scenario planning...
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