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Preparing For and Handling an FDA Inspection



Summary
Preparation will help the business in working as a team and calmly handling all unexpected visitors and inspections. Detailed standard operating procedures are a teaching tool and help develop more consistent processes which will result in more consistent results. Developing better training, standardization, and documentation practices will help prevent and track errors and deviations in processes. Using professional and precise communication in house and with inspectors from any agency is beneficial in helping your business.

Objectives:
Outline how to prepare for the FDA inspection
Identify How to handle an FDA inspector when they are on site
Define Responses to 483s or warning letters

This is a knowledge-based CE activity and is targeted to pharmacists and technicians.

ACPE logo The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this program for 1.0 contact hour (0.1 CEUs) of continuing education credit for pharmacists and technicians. ACPE UAN: 0201-0000-17-030-L04-P and 0201-0000-17-030-L04-T.

If you are interested in earning credit for this program, please note that you will be asked to enter your NABP e-Profile ID and date of birth during the credit selection step of the registration process. If you have not yet registered your NABP e-Profile ID, please visit www.nabp.net.

Presenters
Linda Cappellini Stizza, RPh, FACA
Linda Cappellini Stizza has 20 years of experience in non-sterile and sterile pharmacy compounding and auditing. Over these years, Linda has worked as a Compounding Pharmacist, Director of Laboratory Services, and Director of Laboratory Quality. During her career, Linda has participated in all phases of aseptic facility planning, SOP development, training, and compliance auditing. She served as the primary pharmacy contact for the FDA during their inspections.

In December 2015, Linda...More

How To Attend
Join the live program from your office, home, or hotel room using a computer with high speed internet. You may ask questions, participate in surveys, and post comments from your computer during the program. Please note that credit (if available) is only provided to registered attendees participating at their own computer and phone. Simple instructions with a link to the program will be sent when you register and again the day before the webinar.

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Credit
If applicable, you may obtain credit in multiple jurisdictions simultaneously for this program (see pending/approved list below). Registrants in jurisdictions not listed below will receive a Certificate of Attendance/Completion that may or may not meet credit requirements in other jurisdictions. Where applicable, credit will be only awarded to a paid registrant attending the live program at their own computer and phone.

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