Practical Strategies for Compliance with USP <800>: Hazardous Drug Compliance and Safety in 2019

Date: Wednesday, 27 February 2019 | Time: 11:30 AM PST, 02:30 PM EST | Duration: 90 Minutes
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This course will cover the current regulations and importance of preparing and handling sterile and hazardous pharmaceuticals. On December 1, 2019, USP Chapter <800> will become fully enforceable by regulators. This chapter addresses the physical environment and equipment needed to maintain sterility and protect the 8 million healthcare workers potentially exposed to hazardous vapors and particles each year. With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter.
Hazardous Drug Compliance and Safety in 2019
Instructor: Igor Gorsky
Product ID: 504142
It should be noted that this chapter describes practice and quality standards for handling hazardous drugs to promote patient safety, worker safety, and environmental protection. Handling HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration and disposal of sterile and non-sterile products and preparations.

Objectives of the Presentation
This webinar discusses USP General Chapter<800>Hazardous Drugs—Handling In Healthcare Settings including a discussion on:
  • what are considered to be hazardous drugs
  • what are the containment requirements and the types of possible exposure
  • what are the responsibilities of personnel and
  • What are the controls that must be in place, what PPE is and how it should be used, maintained and disposed?
Why Should you Attend
Join expert speaker Igor Gorsky, for this 90-minute webinar, as he dives into the different types of hazardous drugs and the requirements for compliance. Igor will also teach participants how to perform an Assessment of Risk and how to stay safe when handling hazardous drugs.

Occupational exposure to hazardous drugs poses a threat to the safety of healthcare personnel. This chapter applies to all healthcare personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians' practice facilities, or veterinarians' offices). Personnel who may potentially be exposed to HDs include, but are not limited to: pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.

Areas Covered
  • A list of HD's
  • Facility Design and Engineering Controls
  • Personnel and Training
  • Safe Work Practices
  • Proper use of appropriate Personal Protective Equipment (PPE) & Maintenance
  • Policies for HD waste segregation and disposal
  • Risk based policies
Who will Benefit
  • Warehouse personnel
  • Regulatory officers
  • Accreditation specialists
  • Safety officers
  • Pharmacists
  • Any healthcare staff who work with hazardous drugs
  • Safety personnel
  • Engineering and Maintenance
  • Operations personnel
  • Quality Assurance
  • Quality Control
  • Validation
  • Pharmacy technicians
  • Nurses
  • Physicians
  • Industrial workers that handle HD products
  • Pharmacy owner, hospital manager, building manager
$200
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Instructor Profile:
Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition he had been a presenter at Interphex. He is also very active with PDA participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.
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