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179 results of "Life Sciences x" and "FDA Compliance x"
Live Webinar

Investigating OOS results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...

Live Webinar

CAPA Under U.S. FDA / CGMPs and EU MDR / ISO

CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus.The roles of Failure Investigation a ...

Live Webinar

Preventative Controls for Allergen Risk Mitigation Under FSMA

A five-layered approach to Allergen Management will be described, with latest approaches for cleaning, Validation, monitoring and Preventative Controls now required under FSMA (Food Safety Modernization Act) to incorporate in your Food Safety Plan. Insights fo ...

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • Apr 25, 2019
Live Webinar

FDA Rules for Pharmaceutical Analytical Method Validation

FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they ...

Live Webinar

cGMP Water Systems – How to Avoid Their Typical Emergencies & Problems

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

Live Webinar

Compliance with the New ICH GCP Revision 2 Addendum – Know the How?

This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites. This will enable y ...

  • Basic & Intermediate
  • 60 Mins
  • Laura Brown
  • May 01, 2019
Live Webinar

Process Validation for Drugs and Biologics

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. Attendees will learn how to establish an effective process validation system and inte ...

Live Webinar

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

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 ...

Live Webinar

Quality Control of Microbiological Media, Reagents and Test Kits

During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories to assess the acceptability of the performance of analytical mat ...