BRUNCH WITH GXP AUDITOR
IN ENGLISH
10:00
February 24
Thursday
Free of charge

about the event:

Review of frequent audit and inspection findings based
on FDA and EMA experiences

Failure to follow the investigational plan, insufficient PI control, and informed consent irregularities continue to rank high on the list of top findings in FDA and EMA inspections.


In this Brunch with GxP auditor, together with our international expert's colleagues, we will look at real-world examples of some of the top inspection findings from 2021 and discuss appropriate CAPAs, providing listeners with solutions to avoid common pitfalls and ultimately, inspection findings in the future.


Correct GCP behavior will be reviewed, and lessons gained

will be utilized to prevent these results from occurring again. Participants are invited to share their experiences as they explore approaches and instruments to help in compliance

via suitable ICH-GCP practices.

Guest experts
Maxim Bunimovich,
MD, MRQA
The QARP, CEO and Founder
  • Quality Management Systems
  • QA & QC
  • Independent auditing, inspection headiness and hosting
  • CAPA development
  • Root Cause Analysis
  • Risks identification, assessment, and management
  • SOPs and instructions development
  • Quality Assurance plans preparation
  • GCP training and educational activities
Polina Gremyakova, MRQA
The QARP, Deputy director
  • Quality Management
  • Quality Assurance
  • Quality Control
  • QMS development
  • Root Cause Analysis
  • Risks identification, assessment, and management
  • SOPs and instructions development
  • Quality Assurance plans preparation
Dr. Hanna PreuS, MRQA
Director, Clinical Quality Assurance (Global Process and Continuous Improvement Lead), Astellas Pharma
  • Global Quality & Compliance Expert, Auditor and Business Strategist
  • Quality Culture & Quality Management System
  • Operational Excellence, Process Compliance and Agile Project Management
  • Clinical Operations and Quality Strategy
  • Business Integration and Process Improvement
  • Broad experience in regulatory and GxP standards
Mark Poulton, MRQA
Poulton Quality Solutions Ltd
  • GCP auditing
  • GLP auditing
  • GMP auditing of oral solid dosage forms
  • Training: ICH GCP, Clinical Trial Regulations, Inspection Preparation, CAPAs and Root Cause Analysis
  • Preparation and hosting of EMA, MHRA or FDA GCP inspections
  • Clinical QA consultancy
Stanislav Gneushev
Head of QA department, ICON
February 24, 2022 / 10:00
Leave us your details and we will send you an invitation
by email the day before the event!
Ul. Adama Branickiego 21 U3
Warsaw; Mazowieckie;
Postal Code: 02-972

Russian Federation: 197136,
St. Petersburg, Lenin St., 34
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