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

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

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

Ty Duginske
Ty Duginske
on behalf of Texas Pharmacy Association

$70.00 $ 70.00 $ 70.00

$70.00 $ 70.00 $ 70.00

$ 70.00 $ 70.00 $ 70.00
$ 70.00 $ 70.00 $ 70.00
Normal Price: $70.00 $70.00

Review:

Launch date: 13 Mar 2017
Expiry Date:

Last updated: 15 Mar 2017

Reference: 172150

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Description

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.

Objectives

Objectives
At the conclusion of this program, the pharmacist and technician attendee will be able to:
1.List the areas of the facility that need to be cleaned, sanitized, disinfected or sterilized.
2.Develop compliant procedures for cleanroom cleaning and disinfecting as well as defined cleaning schedules.
3.List the options for disinfecting agents and methods of application.
4.Discuss the requirements for validation, documentation, and environmental monitoring.
5.Explain how tips and case studies help outsourcing facilities demonstrate sustainable compliance.
Ty Duginske

Author Information Play Video Bio

Ty Duginske
on behalf of Texas Pharmacy Association

Ty Duginske Director of Pharmaceuticals & Biologics - Regulatory Compliance Associates Inc. As a 20 year veteran in pharmaceutical and biopharmaceuticals, Ty leads RCA’s pharmaceutical manufacturing and 503(B) outsourcing facility compliance practice. Formerly he worked at Baxter Healthcare Corporation, Catalent Pharma Solutions, CSL.As a 20 year veteran in pharmaceutical and biopharmaceuticals, Ty leads RCA’s pharmaceutical manufacturing and 503(B) outsourcing facility compliance practice. Formerly he worked at Baxter Healthcare Corporation, Catalent Pharma Solutions, CSL Behring and Marsam Pharmaceuticals. Ty serves on the Steering Committee for the ISPE Baseline Guide #3, “Sterile Manufacturing Facilities” and authored the Parenteral Drug Association’s Blow Fill Seal Technical Report chapter. His expertise spans aseptic processing, process validation, facility & engineering design, critical systems, equipment qualification as well as quality assurance/compliance. Ty holds a BS degree in Mechanical Engineering, Materials & Manufacturing from the University of Michigan.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Accreditation Council for Pharmacy Education (ACPE)
  • 1.00 Hours -
    Exam Pass Rate: 75
    -
    Reference: 0201-9999-16-025-H04-P/0201-9999-16-025-H04-T

Faculty and Disclosures

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