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Webinar: Developing a Sustainable Cleaning, Sanitization and Disinfection Program
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Effective cleaning and sanitization programs are essential to ensure quality for drug compounders. In July of last year, the FDA issued new Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This guidance addresses cleaning, sanitization, disinfection and sterility for 503Bs.

12/8/2015
When: Tuesday December 8, 2015
11-12 PM
Where: Webinar
Presenter: Andrew Harrison, Chief Regulatory Affairs Officer & General Counsel
Contact: Akilah Williams
425-228-7171 ext: 0

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Developing a Sustainable Cleaning, Sanitization and Disinfection Program - Don't Get Left Behind on the New FDA Guidelines


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Summary

Effective cleaning and sanitization programs are essential to ensure quality for drug compounders. In July of last year, the FDA issued new Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This guidance addresses cleaning, sanitization, disinfection and sterility for 503Bs. Because the guideline is still in the public comment phase of the regulatory process, now is the time to understand the requirements and ensure compliance for your facility.

Accreditation Information:
This lesson 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 hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. 0201-9999-15-145-L04-P; 0201-9999-15-145-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 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.

CE credit and certificates of attendance will be provided only to those individuals who registered and logged into the webinar online. If you want CE credit and your certificate of attendance, you must have purchased the program and logged into the web portion under that registration so that we can verify attendance.

Learning Objectives:
At the conclusion of this program, the pharmacist and technician attendee will be able to:
  • List the areas of the facility that need to be cleaned, sanitized, disinfected or sterilized.
  • Develop compliant procedures for cleanroom cleaning and disinfecting as well as defined cleaning schedules.
  • List the options for disinfecting agents and methods of application.
  • Discuss the requirements for validation, documentation, and environmental monitoring.
  • Explain how tips and case studies help outsourcing facilities demonstrate sustainable compliance.
Presenters
Andrew Harrison
Chief Regulatory Affairs Officer & General Counsel - Regulatory Compliance Associates, Inc.
Andrew Harrison is the Chief Regulatory Affairs Officer & General Counsel at Regulatory Compliance Associates, Inc. (RCA). RCA has deep experience in helping 503Bs and recently counseled one of the first outsourcing facilities to remediate FDA’s...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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