Online Webinar :Key Considerations for Cleanroom Design and Facility Validation

Website http://c2gowebinars.com/product/?topic=cleanroom-design-facility-validation | Edit Freely

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Deadline: June 07, 2016 | Date: June 07, 2016

Venue/Country: Online, U.S.A

Updated: 2016-05-03 16:54:01 (GMT+9)

Call For Papers - CFP

This seminar is intended to discuss FDA regulations and the requirements for an effective cleanroom and facility validation as part of good manufacturing practices (CGMP) for sterile drug and biological products.

When designing a cleanroom, many factors should be considered to adequately implement the requirements for an effective cleanroom design and validation. Otherwise, it can be costly and time-consuming later.

In this seminar, the speaker will present what firms should know about the statutory and regulatory requirements so that the industry can implement good manufacturing practices to ensure an effective cleanroom design and validation.

This seminar will greatly help you understand and establish an effective environmental monitoring program in view of CGMP (USP, ISO and FDA recommendations).

The speaker will walk you through the FDA compliant practices.

Areas To Be Covered in this Seminar:

Laws and Regulations

Definitions

CGMP Requirements for Pharmaceutical Industry

Regulations Governing Buildings and Facilities

International Standards and Guidance Documents: ISO, USP, and FDA

Comparative Overview of Air and Cleanroom Classification: FDA, ISO and EU EMA

What to Consider Designing a Cleanroom

Cleanroom Validation: Principles and Testing

Determining What Tests to Perform During a Cleanroom Validation

Key Requirements for Personnel Training, Qualification and Monitoring

Important Laboratory Controls

Implementing an Effective Monitoring Program

FDA Enforcement Actions

PASS-IT Suggestions (Best Practices)

Who will benefit:

Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.

Compliance Officers

Regulatory Affairs

Clinical Affairs

Quality Assurance

Laboratory Personnel

IT Professionals

R&D

Consultants

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of attendance

For Registration : http://c2gowebinars.com/product/?topic=cleanroom-design-facility-validation

Note: Use coupon code    and get 15% off on registration.