Education event

Sterile Compounding Pharmacies — Planning, Construction and Licensing Guidance Webinar
Gain insights from CA Board of Pharmacy, OSHPD, CDPH Licensing & Certification

Register now
April 21, 2017
10:00 a.m. – 12:00 p.m., Pacific Time
Registration is now closed, please contact the Education Department at (916) 552-7637.

Overview

Effective January 2017, hospitals that perform sterile compounding must meet new regulatory requirements from the California State Board of Pharmacy. Beyond updating processes and procedures, hospitals will be required to improve or reconfigure facilities for ventilation, install new equipment for sterility and ensure employee protections.

This process is new and requires collaboration, coordination and a focused approach for successful implementation. CHA has gathered representatives from three California government entities — the Board of Pharmacy, Office of Statewide Health Planning and Development (OSHPD) Facilities Development Division and Department of Public Health Licensing and Certification Program — to share insights crucial to compliant implementation of the sterile compounding regulations.

Make plans now to participate.

Recommended for:

Chief operating officers, chief compliance officers, directors of pharmacies, plant managers, construction directors and managers, architects and engineers, inspectors of record.

Program supported by:
American Institute of Architects California Council
(AIACC members may register at the CHA member rate.)

Agenda

Board of Pharmacy

  • Brief review of regulations
  • Waiver process, managing rejections and renewals
  • While under construction — strategies for maintaining services
  • Project completion and application for new sterile compounding license

OSHPD Process and New Advisory Guide

  • Why sterile compounding projects are not business-as-usual construction
  • Highlights of new OSHPD Advisory Guide
  • Preparing for construction — planning, process, timelines
  • OSHPD project numbers — when to get, what’s required, length of use
  • Steps to improve the review and speed plan approval

Licensing and Certification

  • Application and approval required — Sacramento’s Centralized Applications Unit (CAU)
  • Regulatory and statutory considerations
  • Using “Mobile Health Care Units” — approval and inspection required
  • Project completion and scheduling licensing visit — preparation for final inspection and approval prior to use

Faculty

Christine Acosta, PharmD, Supervising Inspector, California State Board of Pharmacy

Paul A. Coleman, Deputy Director, Facilities Development Division, California Office of Statewide Health Planning and Development (OSHPD)

Diana Scaturro, Supervisor, Rapid Review Unit, Facilities Development Division, OSHPD

Robert Menét, PharmD, Chief Pharmaceutical Consultant, Licensing and Certification Program, California Department of Public Health

CEs

Full participation in the webinar is required to receive professional continuing education (CE) credit. The registrant must complete an online evaluation, attest to participation and, when required, provide a professional license number.

Architects — This program has been approved by the American Institute of Architects California Council to award 2 AIA/CES HSW units of continuing education credit. Learning objectives:

  • Understand why sterile compounding projects are not “business as usual construction” and steps to improve the review and speed plan approval.
  • Gain perspective about the steps it takes to prepare for construction — planning, process, timelines — for these specialized facilities.
  • Understand expectations regarding licensing and certification, specifically relating to the policies and procedures for successful surveys while under construction.
  • Learn how to develop strategies for maintaining services while under construction.

Compliance — The Compliance Certification Board (CCB)® has approved this event for up to 2.4 CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.

Health Care Executives — CHA is authorized to award 2.0 hours of pre-approved ACHE Qualified Education credit for this program toward advancement, or recertification, in the American College of Healthcare Executives. Participants in this program who wish to have the continuing education hours applied toward ACHE Qualified Education credit must self-report their participation. To self-report, participants must log into their MyACHE account and select ACHE Qualified Education Credit.

Tuition

Members $185
Nonmembers $250
(AIACC members may register at the CHA member rate.)
Multiple staff can participate from one location for one tuition fee.

Members are CHA member hospitals, CHA associate members and government agencies. Nonmembers are limited to non-hospital health care providers, clinics, post-acute facilities, and consultants, insurance companies, law firms and other entities that serve hospitals. Education programs and publications are a membership benefit and are not available to eligible nonmember California hospitals.

Cancellation Policy/Late Payment: A $50 non-refundable processing fee will be retained for each cancellation. Cancellations must be made in writing seven or more business days prior to the scheduled session and emailed to education@calhospital.org. No refunds will be made after these dates. Substitutions are encouraged. Please note that payment is due on or before the program. Payments not received by the program date may be subject to a 10% late fee. In the unlikely event the program is cancelled, CHA will fully refund paid participants within 30 days.

Special Accommodations or Questions: If you require special accommodations pursuant to the Americans with Disabilities Act, or have other questions, please call (916) 552-7637.

Commands