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131 results of "Life Sciences x" and "Lab Compliance x"
Live Webinar

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...

Live Webinar

The Transfer of Validated Methods

This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Dec 05, 2022
Live Webinar

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Dec 19, 2022
Live Webinar

How to Deal with Bad Results Under GLP

Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts a ...

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Jan 04, 2023
Live Webinar

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes the development of a company philosophy and approach and incorporating it into an overall computer syst ...

Live Webinar

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Jan 18, 2023
Live Webinar

Vendor Audit for Systems and Services for FDA-Regulated Systems

This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...

Live Webinar

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

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

Live Webinar

Cloud and Software-as-a-Service (SaaS) Vendors: Approach to Validation for FDA-Regulated System

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.  Th ...

Live Webinar

Medical Device Trends in FDA Compliance and Enforcement

This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the devic ...