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61 results of "Life Sciences" and "Clinical Research"
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 clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most i ...

Live Webinar

Steam Sterilization Microbiology and Autoclave Performance Qualification

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization proc ...

Live Webinar

Human Error Reduction In GMP Manufacturing/Floor

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From p ...

Live Webinar

CAPA Simplified – A One-form, Easy-to-Complete, Method for Simplifying your CAPA Process

This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), e ...

Live Webinar

Review of the Changes for ISO 13485:2016 Implementation and Comparison

The International Organization for Standardization (ISO) was established to share knowledge and develop voluntary, consensus-based, market-relevant standards that are designed to help support innovation and to provide solutions to tackle global issues. ISO is ...

Live Webinar

Assessing Immunogenicity to Biologics

Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. Similarity to critical proteins in human physiology or possible interference with endogenous pathways in ...

Live Webinar

Understanding and Implementing a Quality by Design Program

Understand what is meant by Quality by Design Understand the benefits from applying a QbD approach Provide key steps to implement a QbD program Understand what the important tools used to implement a QbD approach

Live Webinar

How to Roll Out a POC Molecular Diagnostic

Point of care diagnostics is a familiar technology to healthcare practitioners. All sorts of tests are performed close to the patient to assist in making healthcare treatment decisions. Recent developments in molecular diagnostics have made it possible for PCR ...

  • Basic & Intermediate
  • 60 Mins
  • Todd Graham
  • Mar 13, 2019
Live Webinar

Standadardizing Operations to Eliminate Human Error Potential in Life Sciences Operations

Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even ...

Live Webinar

Risk Based Approach to Auditing Quality Suppliers and Vendors

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implem ...