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364 results of "Life Sciences x"
Live Webinar

Advertising and Promotional material compliance and review process

The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...

Live Webinar

FDA’s Evolving Approach to Medical Software Regulation

As technology continues to advance in all areas of healthcare, the software has become an essential part of virtually all products, integrated widely into digital platforms that serve medical purposes The FDA has recognized its traditional approach to devic ...

Live Webinar

Pharmaceutical Contamination and Food Safety

What foods have drugs in them? How do the drugs get there? What impact can these foods have on humans? What impact can a recall of pharmaceutically contaminated foods have on your business? Processors, packers, distributors and other food supply chain members ...

  • Basic & Intermediate
  • 60 Mins
  • John Ryan
  • Jul 02, 2019
Live Webinar

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.  Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...

Live Webinar

FDA Internal Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages.The webinar will address aspects of the review process, SOP p ...

Live Webinar

Equipment Qualification and Process Validation

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made o ...

Live Webinar

Effective Standard Operating Procedure (SOPs) Development

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.  

Live Webinar

Cold Chain Best Practices and the Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) is the biggest regulatory overhaul in the history of the U.S. Food and Drug Administration (FDA). The FSMA is a paradigm shift that moves the focus from food inspections to preventative measures and process compliance. ...

  • Basic & Intermediate
  • 60 Mins
  • Joe Lynch
  • Jul 10, 2019
Live Webinar

Medical Device Cyber-security following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market.The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communi ...

Live Webinar

Data Integrity and Privacy: compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...