FDA / EU Inspections – Getting Prepared – By Compliance Global Inc.



Speaker: Marie Dorat


This webinar is a comparative look at FDA & EU regulations to 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 regulations training and EU regulations and standards apply for pharmaceuticals, biologics and medical devices. Failure to conform to these good clinical practice training may result in concerns about quality and integrity. Inspections are critical to the success of business on several levels. Therefore, being appropriately prepared and management of the inspection and audit process are critical activities. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.
This webinar has been specifically designed to help attendees prepare for FDA and EU inspection. 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 through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out.

Areas Covered in this Webinar:

• Differences between FDA and EU inspections including the FDA and EU joint inspection programmer
• How to prepare for EMA and FDA audit training
• How to plan for an audit or inspection using checklists/ FDA/EMEA inspection guidelines
• Tips for employees before the inspect
• Tips on proper responses to prepare for audit/inspection interviews
• Setting up a triage to ensure that required documents are available
• How to interact with the inspectors—DOs and DON’Ts
• How to reply to inspection reports, form 483 fda’s and EU inspection finding
• Post inspection actions – implementing appropriate CAPAs in response to audit findings
Learning Objectives
• What to expect during an FDA/EU inspection
• How to be prepared – with special focus on GCP inspections

Who Will Benefit:

• Quality Assurance Managers and Auditors
• Regulatory Affairs Personnel
• Document Management Professionals
• Other Professionals who want to know more about inspection guidelines



For registration: https://www.complianceglobal.us/product/700264

About Compliance Global Inc:

Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.

Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Ad Reference ID: 11156695bd1092ff

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