Edyta's Top Tips to Becoming Inspection Ready
We spoke to Edyta Zbirog-Lukawska, Central Europe Quality and Compliance Adviser (Affiliate Process and Training Adviser) to hear her thoughts on what the top tips are for becoming inspection ready. In this infographic, she shares these along with further insights into her experiences with how to prepare and sustain inspection readiness.
We need to embrace the ‘Quality by Design’ mind-set and embed quality in each and every task from the beginning”, says Edyta when telling Pharma IQ of her first tip. “By thinking about quality from the beginning, we can ensure inspection readiness at every stage of the study, and not be stressed out when the inspection is announced!”
In this piece Edyta focuses on the importance of Quality by design to ensure a smooth process and avoid these critical pitfalls and failures that can come with unpreparedness. Edyta also tells Pharma IQ how her best advice comes in the form of R.E.A.D.
rule, find out how this can be applied to the inspection process in the full infographic here:
Edyta will be joining us at GCP Inspection Readiness to co-facilitate the Mock Inspection Workshop Day, guiding attendees through her experiences with recent inspections and advising on best practice to implement going forward. Find out more about this interactive workshop below:
Introduction:
Complete your journey by putting your new skills to the test in this mock inspection workshop. Join Grünenthal and Roche as they guide you through their most recent inspections, including preparatory and follow-up activities. By engaging in interactive break-out sessions and real life case studies, will you go home with the confidence, you ARE inspection ready.
Session Objectives:
- Develop a deeper understanding of what efforts must be taken before a mock inspection
- Design strategies on how you can plan your own mock inspection
- Understand the benefits and pitfalls of a mock inspection
- Analyse what an inspection could mean for our company or study site
- Define the similarities and differences of a sponsor and site inspection
Key-Take Homes:
- Understand how to effectively prepare for a mock inspection, including back office organisation
- Discover the importance of mock-interviews and learn how you can train potential interviewees
- Learn how to turn a tricky inspection around by understanding how you can adapt during your inspection
- Enforce lasting change by successfully implanting follow-up activities
- Clarify the differences between a mock inspection and a real one