ComplianceOnline

Principles of Sterile Manufacturing

Instructor: James Harris(PhD)
Product ID: 700991
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.

The manufacture of sterile medical products and medications requires all of the things demanded of non-sterile manufacturing plus a long list of additional procedures, techniques, and specialized facilities required to assure the enhanced cleanliness and sterility that is required of these very special products. A detailed treatment of this subject would take two or three days. To meet the time constraints of this presentation, we will limit the discussion to clean room design and operation - the basic concepts of sterile operation.

Areas Covered in the seminar:

  • Clean Room design - materials of construction; air locks. Air showers, material flow, people movement, and air flow.
  • Containment.
  • Gowning.
  • Sterile Procedure.
  • Process control.
  • Environmental control and monitoring.
  • Assurance of sterility.
  • Diofference between pharmaceutical & electronics.

Who Will Benefit:

This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.

  • Managers
  • Supervisors
  • Leaders
  • Operators
  • QA inspectors
  • Scientists
  • Auditors and researchers wor work in manufacturing
  • Quality assurance/quality control
  • Regulatory
  • Research and development in the pharmaceutical and biologics industries as well as similar workers involved in the medical device and diagnostics industries.

Instructor Profile:

James R. Harris, PhD held VP level management positions in several of the world’s largest pharmaceutical firms before forming a consulting organization that worked globally serving pharmaceutical and related industries in over 60 countries.

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