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.
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.
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.
Presenter: 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 formed an LLC, Quality Compounding Consultants, to personally assist compounding pharmacies and outsourcing facilities in operations and compliance. She has successfully prepared facilities for FDA, ACHC, NABP, and State Board of Pharmacy audits. She has also assisted facilities in preparing responses to 483s and Warning letters and then in making the needed corrections in their facility to comply with their response.
Linda was awarded the Scheffe Scholar designation by the American College of Apothecaries and designated as Preceptor of the Year by Midwestern University College of Pharmacy. She received the Philosophy in Action Award for Quality and Excellence for improving the quality of pharmacy services at Catholic Healthcare West.
How To Attend
Join the live program from your office, home, or hotel room using a computer for the web portion and telephone for the audio portion. You may ask questions, participate in surveys, and post comments from your computer during the program. You may also invite colleagues to watch the program from a shared computer or projection screen and speakerphone. 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.