Overview

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP to ensure compliance with regulatory expectations are met.

Why should you attend

Course Objectives: At the completion of this course, attendees will be able to:

  • Explain the difference between Aseptic and Bulk processing
  • Understand facility and personnel requirements necessary to maintain microbial control
  • Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
  • Understand the gowning requirements associated with different cleanroom classifications
  • Explain basic principles of aseptic processing, including:
  • Cleanliness classifications
  • Proper Engineering controls
  • Process differences between aseptically produced and terminally sterilized product
  • Relation of manufacturing and handling procedures to sources of product contamination
  • The differences between cleaning, disinfection and sanitization
  • Proper cleaning / disinfectant technique
  • Elements of a robust environmental program and why EM is important
  • The purpose of media fills, and elements critical to their success
  • The role of isolator technology
  • Identify behaviors that are or are not appropriate when working in controlled areas, and why
  • Identify ways that they can impact/improve site-specific EM and aseptic behavior issues

Webinar Takeaway

Topic 1: Basic Micro Review

• The role of environmental monitoring

• Types & sources of microorganisms

• The impact of microorganisms on product and patient health and safety

Topic 2: Review Aseptic Processing Basics

• Cleanliness classifications

• Process differences between aseptically produced and terminally sterilized product

• Relation of manufacturing and handling procedures to sources of product contamination

• The differences between and the purposes of cleaning, disinfection and sanitization

• Proper cleaning techniques

• The role of isolator technology

Topic 3: Review Clean Area Behaviors

• Personnel gowning requirements

• Good clean area behaviors/practices

• Practices to avoid – and why

• Review site-specific EM/aseptic behavior observations/risks & ask attendees to brainstorm ways to change/improve/eliminate these behaviors & risks

Topic 4: Aseptic Validation

• The purpose of media fills, and elements critical to their success

Who will benefit

Operations employees who are required to enter controlled environments as part of their job function – includes some or all of the employees in the following departments:

  • Production
  • QC Micro
  • Engineering & Validation
  • Facilities / Maintenance
  • Quality Assurance

Industries who can attend

This 180-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Faculty Kelly Thomas


Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  

Faculty Kelly Thomas

Choose a Purchase Options

$399

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 180-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$499

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.