Do You Know GMP Compliance Audit: How Best to Prepare for it

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Category Pharma ; Biotechnology

Deadline: April 17, 2013 | Date: April 18, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-09 00:34:33 (GMT+9)

Call For Papers - CFP

This webinar will provide the attendees with a checklist of the most common areas of focus by regulatory auditors during GMP Compliance Audits. With an ever increasing number of recent warning letters and Consent Decrees issued in the last several years, companies must know what inspectors are focusing on and how best to evaluate their own state of compliance. Preparation is a key factor to successfully get through an audit and this webinar will give attendees some valuable tips to achieve this.

Description of the topic

Companies today regulated by the FDA are increasingly aware of the enforcement actions by the agency with respect to regulatory compliance. This webinar will highlight the 10 most common GMP deficiencies cited by auditors in 2011, along with the significant increase in warning letters issued over the last 3 years. The review of such information lays the groundwork for which companies can use to evaluate their own state of compliance and how best to prepare for such an audit. The webinar will briefly examine each of the deficiencies and where companies fall short in meeting the regulatory requirements.

In addition to the most common GMP deficiencies given to industry in 2011, the webinar will also help attendees in preparing an audit checklist that can be used to evaluate their own state of compliance. Attendees will be given several steps that can be used to help avoid regulatory trouble in this time of enforcement activities. Attendees will also be given the opportunity to ask questions and actual case examples will be discussed to highlight some of the topics covered. This webinar is a wealth of information for those involved with supply chain activities, manufacturing, validation and quality assurance to name a few.

Areas Covered In the Seminar

Review common and recent industry cited GMP deficiencies.

Discuss common mistakes made by industry relative to deficiencies noted.

Review topics to include for an audit checklist to evaluate your company’s state of compliance.

Discuss how to help avoid regulatory trouble.

Who will benefit

Quality Assurance

Quality Control

Manufacturing

Production

Regulatory

Laboratory Personnel

Management

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-Certificate & Presentation

About Speaker

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 for VTS Consultants, Inc located in Amhesrt, MA. Specifically, his responsibilities 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. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

Speaker : Kenneth J. Christie

Product ID : F62199

Schedule Date :

Thursday, April 18, 2013

duration : 01:00 to 02:30 PM EST

https://compliance2go.com/index.php?option=com_training&speakerkey=53&productKey=219