IN ENGLISH
Friday
(16:00 Moscow time)
about the event:
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. |
- Maxim Bunimovich,
MD, MRQAThe 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, MRQAThe 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, MRQADirector, 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, MRQAPoulton 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 GneushevHead of QA department, ICON
by email the day before the event!
Warsaw; Mazowieckie;
Postal Code: 02-972