Current Regulatory Requirements for Sterile Products

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Category FDA GXP Compliance;

Deadline: December 05, 2014 | Date: December 05, 2014

Venue/Country: Palo Alto, U.S.A

Updated: 2014-12-02 22:00:50 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

This webinar will highlight and summarize the following main components relating to current validation requirements for sterile products:

Review of current regulations and guidance documents

Typical expectations when aseptic processing is involved

Expectations for protocols used to document the qualification of associated equipment, utilities and processes

Recently cited regulatory deficiencies

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

QA/QC

Manufacturing

Engineering

Validation

Regulatory

Instructor Profile:

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc., located in Amhesrt, MA. His responsibilities specifically include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis.

Use coupon code 232082 and get 10% off on registration.