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203 results of "Life Sciences x" and "Quality Mangement x"
Live Webinar

HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information

This training on HIPAA compliance will teach the attendees how to examine their security policies, practices, and risk issues to find and fill any gaps in the documentation that is required by the HIPAA rules to show compliance, survive audits, and avoid enfor ...

Live Webinar

Process Validation - Overview Of Why And How

This webinar will provide an understanding of FDA and ISO 13485 requirements for process validation and how to implement them. The session will cover the basics of this important topic for those who are new to the quality or new to process validation. It will ...

  • Basic & Intermediate
  • 60 Mins
  • Betty Lane
  • Sep 19, 2019
Live Webinar

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, tem ...

  • Basic & Intermediate
  • 60 Mins
  • Roger Cowan
  • Sep 24, 2019
Live Webinar

Adverse Event Reporting and Product Recalls

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...

Live Webinar

Implementation and Management of GMP Data Integrity

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hyb ...

Live Webinar

Food Safety Modernization Act Prevention Controls: Cross Contact and Cross Contamination

About 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is l ...

Live Webinar

Medical Device Software Verification and Validation

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

Live Webinar

How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

This webinar will include things that it is important to know about FDA inspections. Using the self-auditing process to correct problems before the FDA or customer arrives will be discussed. How to prepare for an FDA inspection and how to behave during one wil ...

Live Webinar

FDA Best Audit Behavior Practices – Do’s and Don’ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, a ...

Live Webinar

CAPA Under U.S. FDA / CGMPs and EU MDR / ISO

CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus. The roles of Failure Investigation ...