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    • Live Courses/Webinars
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HomeManufacturing (GMP)Understanding Aseptic Technique & Cleanroom Behavior: Avoiding Human Error

Understanding Aseptic Technique & Cleanroom Behavior: Avoiding Human Error

Teachers
Danielle DeLucy
Category:
Manufacturing (GMP)/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

The sterility, safety, and efficacy of your products is paramount to success, especially in injectables and biologics, there simply is no room for mistakes.

Compounded sterile products utilize aseptic techniques that prevent microorganism contamination. This activity is critical for the successful manufacturing of safe, sterile therapeutics. The procedure involves using specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.  But often, this technique is overlooked by firms and staff, leading to sloppy production that is most often caused by human error.

LEARNING OBJECTIVES

During this interactive session, you will learn simple steps to improve your aseptic efforts and be able to:

  • Define aseptic processing (AP)
  • Stated the differences between terminal sterilization and AP
  • Identify the proper personnel behavior in a cleanroom to keep human error out of the equation
  • Describe facility design and how it impacts the product
  • Explain proper environmental monitoring practices and systems used

Finally, this course reviews how quality systems help define requirements for aseptic technique/cleanrooms, and how to properly maintain these environments.

Who Should Attend

WHO SHOULD ATTEND

This course benefits aseptic operators, aseptic sample handlers, and personnel working in a Biological Safety Cabinet (BSC).  This course also assists management and quality assurance staff by highlighting how to operate in a clean room environment.

Proper facility design, personnel gowning, and the equipment needed to conduct environmental monitoring are highlighted to give context, so those responsible for these areas are encouraged to attend.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Contact us at 215-675-1800, Option 3 (9am – 5pm EST, Monday-Friday).

About Instructors

Danielle DeLucy
Danielle is a subject matter expert specializing in quality assurance and quality systems. She assists companies facing warning letters and consent decrees as well as those wishing to improve GxP practices and establish more robust quality systems.

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Clear
Duration: 90 minutes
On-Demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials (GCP Training) (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Manufacturing (GMP) (92)
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  • On-Demand Courses (239)
  • Quality (52)
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  • Special Packages (5)

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
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  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EHRs EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management QMS Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials (GCP Training)
  • Coronavirus / COVID-19
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  • Manufacturing (GMP)
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