Although we all know the important consequences of FDA Clinical Investigator Inspections at your site, you will insure that you have done everything to be ready.
How to answer questions: what to say, how to say it, what you should not say. This significant assistance will enable you to improve on your procedures – even if you thought you were already prepared.
Why Should You Attend:
Have you done everything you can to prepare for your next FDA Inspection? Do you have an SOP for Regulatory Inspections? Do your employees know what to do when they get that phone call from security or a receptionist? Who should security/receptionist call when FDA arrives unannounced at your firm? That’s right, FDA does not schedule an inspection – they just show up, present their credentials and state we’re her for an inspection.
Don’t panic! Be prepared! Learn how to go about writing SOP for FDA Inspections. Make sure your people are adequately trained on this SOP document so they don’t “freak-out” when two, three or four FDA Investigators surprise you.
Areas Covered in this Webinar:
You will be more successful and have better teamwork during inspections by knowing the do’s and don’ts before you make any serious errors. Improving your preparedness helps your continuous quality improvement initiatives.
• Learn how to write standard operating procedure for FDA Inspections
• Learn what things need to be done to ensure you are ready for FDA Surprise Inspections and other regulatory inspections
• Acquire the knowledge on how to behave during these inspections – how to answer their questions, what not to say and where you should have FDA stay while they are on-site
• Learn how to prepare document records so they could be retrieved quickly
• Deviations, OOS and Complaint Investigations need to be completed
• Are your Master Production and Batch Production Records organized and ready for review? Are your stability studies organized and prepared for scrutiny by FDA?
• Learn how to adequately maintain your facility and equipment
Who Will Benefit:
• Pharmaceutical Manufacturers (Quality Assurance, Quality Control, Regulatory Affairs and Facilities/Maintenance Groups)
• API Manufacturers
• Contract Manufacturing Organizations
• Contract Testing Laboratories
• Research and Development Groups
• Virtual Companies
Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.
Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.
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