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

Human Error and Management Systems: Designing Errors Out

If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization ...

Live Webinar

Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance

This interactive webinar explains how to configure and validate GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...

Live Webinar

STRATEGIC SOURCING – Foundation for Success

Your business performance is directly related to the quality and delivery of materials & services from your supplier.  They play a major role in your success or failure. Recognizing this point requires that we pursue a NEW RELATIONSHIP with our suppliers.  An ...

Live Webinar

Corrective and Preventive Action (CAPA)

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.   Just as lean principles challenge traditional process concepts and "push ...

  • Basic & Intermediate
  • 90 Mins
  • José Mora
  • Jun 14, 2022
Live Webinar

PRACTICAL SUPPLIER SOURCING

Today’s demands for continuous improvement are driving us to ensure that the outside resources we utilize are the very best.   As a result of this thrust, we need to how to do this in Purchasing. The most important area is the source of our supply.   How do ...

Live Webinar

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most im ...

Live Webinar

21 CFR Part 11 Electronic Records/Signatures

The Webinar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.  This includes developing a company philosophy and approach ...

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
  • Jul 12, 2022
Live Webinar

Pharmaceutical Compressed Air:Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system are essential for maintaining a quali ...

Live Webinar

Best Practices for Preparing for an FDA Computer System Audit

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.  This webinar will help you understand the FDA’s current thinking on computer sys ...