Aseptic Processing: Preparing Staff and Programs For Compliance

Teachers
Joanna Gallant
Category:
Manufacturing/On Demand Courses/
Clear
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Aseptic processing deficiencies are one of the most cited observations in FDA 483s and warning letters. Since regional regulatory bodies each have their own requirements, staying compliant can be a confusing and complex challenge.  However, simple planning and implementing best practices in accordance with a variety of cGMP guidances can help ensure that your organization is prepared for an audit.

Producing high quality product requires effective fill/finish processes, solid aseptic techniques, detailed procedures, and well-qualified personnel who understand the impact of their actions on the product, process and environment.  This course will give you the tools to understand the areas of concern, why they are so often cited, and tools to build an aseptic training program that will produce quality product and withstand regulatory inspection.

This 90-minute course will teach you how to:

  • Identify threats to product sterility by understanding the typical issues FDA & EU inspectors find ‐ and cite
  • Assess your own process for effective practices
  • Implement aseptic processing training programs that will withstand any level of regulatory scrutiny

Who Should Attend

WHO SHOULD ATTEND

This course will benefit anyone who owns or performs work in a sterile or aseptic production facility environment, including quality, validation, microbiology, facilities, cleaning, environmental monitoring and management personnel from production facilities and contract manufacturers (CMOs) alike.

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.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Joanna Gallant
20+ years of technical and operational experience within pharma, biotech and medical device manufacturing environments.

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