Unit 4: Reading Between the Lines: How to Interpret and Verify Your Cleanroom Certification Report

Only available as part of a package

Participants will learn how to review and interpret cleanroom certification reports to verify compliance with USP <797> standards. Key topics include identifying and evaluating critical report data, documenting personnel presence during testing, and confirming certifier training and competency. The course will also emphasize the importance of signing off on certification reports and ensuring all requirements are met. By the conclusion, attendees will be equipped with the knowledge and skills needed to confidently oversee cleanroom certification processes and maintain compliance in sterile compounding operations.

Learning Objective:

  1. Describe the responsibilities of the designated person, including the need to sign off on the report. 
  2. Ensure certification records for the cleanroom suite meets the requirements of USP <797>.
  3. Identify where to find and interpret information included on a certification report.
  4. Utilize a checklist or structured tool to consistently document, verify, and sign off on certification reports.

NHIA General CE Information

Gene Decaminada, RPh, BSPharm, FNHIA

Pharmacy Manager Home Infusion

Yale New Haven Health

Gene Decaminada is currently the Pharmacy Manager for the Home Infusion Program at Yale New Haven Health Services (YNHHS). NHIA Fellowship Award (2021);  CPA mentor (2021, 2022) YNHHS Mentor (2022); NHIA Peer Review Member (2021); CPA Professional Pharmacy Performance Award (2021); BPS Sterile Compounding Council Member (term concluded 12/31/21); former NHIA National Standards and Sterile Compounding Education Committee member; PTCB Certificate Program instructor CT Community College (2021); CPA Sterile Compounding Conference Committee member; NHIA Sterile Compounding Practice Committee (SCPC) member; Vizient Home Infusion subcommittee member; and a selected member of the Institute for Excellence at YNHHS Lean-In Class of 2022. 

NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy. 

Gene Decaminada has no relevant financial relationships with ineligible companies to disclose.

L Rad Dillon RPh

Founder

Coalition for Compounding Excellence

Rad Dillon graduated from the University of Texas College of Pharmacy in 1981, and shortly thereafter entered the new home infusion industry, working for numerous national and regional providers in various managerial and corporate leadership roles. After ten years as a contract and full-time surveyor for ACHC, he has returned to private consulting. He recently founded the Coalition for Compounding Excellence (CCE), an accrediting organization for 503A compounding pharmacies, whose goal is to provide cost-effective, high-value accreditation services to these pharmacies. He is also a consultant for Gates Healthcare Associated (GHA) and the National Coalition for Drug Quality & Security (NCDQS). Areas of expertise include quality management, sterile compounding facilities and processes, clinical documentation, and hazardous drug handling.

NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy. 

L Rad Dillon has no relevant financial relationships with ineligible companies to disclose.

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Unit 4: Reading Between the Lines: How to Interpret and Verify Your Cleanroom Certification Report
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8 Questions Sterile Compounding Designated Person Certificate Program Unit 4: Reading Between the Lines: How to Interpret and Verify Your Cleanroom Certification Report On Demand, 1.25 CE JA4008389-0000-25-237-H07-P&T & 203344940
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Up to 1.25 medical credits available  |  Certificate available
Up to 1.25 medical credits available  |  Certificate available **PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT** ________________________________________________________________________________________________________________________________________________________________________ NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. Please note that the certificates printed from this platform are invalid as proof of continuing education (CE). For official documentation of CE credits, please print a paper statement of credit from your NABP e-profile.
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