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163 results of "Life Sciences x" and "FDA Compliance x"
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

Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 & Beyond

The cost of prescription drugs in the United States remains a hot-button issue for policymakers and consumers alike The vast majority of the public sees drug prices as unreasonably high with one in four people taking prescription drugs reporting difficulty ...

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 ...

Live Webinar

FDA – Is your cGMP Water System READY for their VISIT

Pharma cGMP Water Systems are very critical to the safe production of patients modifications. Several Departments are required for continued High-Quality operations. These include Quality, Manufacturing, Maintainence and Validation on a daily basis. This prese ...

Live Webinar

Food Allergen Programs: Management of Allergen Cross-Contamination and Validation of Cleaning Procedures to Ensure Effective Removal

A very small amount of some allergens such as nuts can cause adverse reactions, including potentially fatal anaphylactic shock. Consequently, under the Food Safety Modernization Act (FSMA) greater emphasis is placed on allergen management. The food industry mu ...

  • Basic & Intermediate
  • 60 Mins
  • Rotimi Toki
  • Mar 20, 2019
Live Webinar

PK/PD Studies in Drug Discovery and Development

Pharmacokinetics (PK) describes the time course of drugs in the organism i.e. the processes that a drug undergoes after administration. PK, therefore, assesses the absorption, distribution, metabolism, and excretion of new chemical entities. In other words, ...

Live Webinar

FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)

This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do.

Live Webinar

Technical Writing: Best Practices

Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. The term is primarily associated with the pharmaceutical and medical devices industries but applies to documents creat ...

Live Webinar

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs.  These design inputs then form the basis of the design specification, which becomes the design output.  Since design ...

Live Webinar

The Pharmaceutical Quality System: An element of Contemporary Compliance

The term Quality System began appearing in FDA publications and guidance about the turn of the century. In 2008 the FDA and ICH released ICH Q10, The Pharmaceutical Quality System and many of the FDA publications are based on the Quality System philosophy. The ...