FDA vs. EU Inspections - How to Prepare and What are the Differences
Tuesday, November 12, 2013 from 10:00 AM to 11:00 AM (PST)
This training on GCP regulations will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
Why Should You Attend:
FDA and EU GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in concerns about data quality and integrity. Inspections are critical activities that impact business success on several levels. Therefore, preparation and management of the inspection and audit process is an important business activity, not just a distraction from day to day routine.
Potential adverse consequences to the company if an inspection does not go well range from time consuming responses to regulatory observations to publicly available warning letters, delayed product approvals, and the spectre of civil or even criminal litigation by the FDA and EU inspection agencies. These consequences are preventable with good preparation and planning.
This webinar has been specifically designed to help attendees prepare for FDA and EU inspection, particularly since such inspections are increasing and take considerable preparation time. It will provide a background and understanding of the role played by the regulatory inspectors, and the administrative and enforcement powers. Attendees will be taken step by step through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out.
This intensive webinar will provide a concise overview of how to prepare for audits and regulatory inspection for clinical research activities carried out by EU and FDA inspectors. Attendees will hear about the findings from the joint FDA and EU inspection programme being carried out.
Areas Covered in the Webinar:
- Differences between FDA and EU Inspections including the FDA and EU pilot joint inspection programmer
- How to prepare for EMA and FDA audit regulatory affairs and clinical trials
- How to plan for an audit or inspection including using appropriate checklists/ FDA/EMEA inspection guidelines
- Ways to train employees in view of the inspection
- How to prepare for audit/inspection Interviews
- How to ensure that required documentation is in place
- How to interact with the investigator—DOs and DON’Ts
- How to reply to inspection reports and 483’s and warning letters and EU inspection finding
- Post inspection actions and to consider how to respond to the audit/inspection findings
- How to carry out corrective and preventative action for responding to inspection findings
Who will Benefit:
This webinar will provide critical assistance to FDA and EMA regulated companies including professionals in pharmaceutical, biotechnology, CRO, SMO, vendor companies, or study sites including investigator initiated studies that are subject to inspection or audit.
It will also be of interest to personnel such as:
- Clinical development managers and personnel
- Clinical research associates
- Clinical Research archiving and document management personnel
- Quality assurance managers and auditors
- Project Management
- Sponsors and non-commercial sponsors
- Sponsors who have their own laboratories for analyzing clinical trial samples
- Laboratories analyzing samples from clinical trials
- Regulatory affairs
- Clinical trial supply
- Document management
- To those departments who liaise / support clinical trials
- Legal, regulatory authorities and all other professionals who want to know more about regulations and guidelines covering clinical trials.
Dr Laura Brown,PhD, MBA, Diploma Clinical Sciences, is an independent QA and Training Consultant in the Pharmaceutical Industry as Managing Director, LB Training and Development Ltd. , Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff, and Course Director MSC Regulatory Affairs, TOPRA.
Dr. Brown has almost 20 years’ experience of running clinical trials and clinical quality assurance in the pharmaceutical industry, including auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.
She is author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices” (2007). She is also an author of SCRIP’s latest GCP guide and a “Practical Guide to the Clinical Trial Directive. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and on training courses on QA and GXP issues.
She developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (A regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013). She runs many training courses both on public courses and in-company on topics including: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP , Regulatory requirements for Clinical Trials, the clinical trial directive, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection, how to audit etc.
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