Webinar on FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

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Category Medical Devices

Deadline: July 25, 2106 | Date: July 25, 2106

Venue/Country: Online, Canada

Updated: 2016-06-30 18:44:00 (GMT+9)

Call For Papers - CFP

Within the industries of pharma, biotechnology and medical devices, the word ‘audit’ can cause anxiety when you are unaware of how your company’s practices and procedures compare to the rest of the industry. Part of successfully getting through a regulatory audit involves: knowing the applicable regulations, the audit approaches used by regulators, and the common areas of industry deficiencies.

In addressing all these key elements, this webinar will:

Provide attendees a better understanding of the current audit techniques used by the FDA and how they have changed over the years

Analysis of the top 10 most cited GMP drug manufacturing deficiencies over the last year

Review of the significant increase in the number of warning letters issued over the last four years

Review common areas of focus during audits

Provide a template that companies can use to evaluate their own state of compliance

Demonstrate examples to highlight various points discussed

Please Note: This webinar will NOT be available in the Recorded format. This is a LIVE ONLY training.

Areas Covered in the Session :

Changes in FDA audit approaches

Areas of focus during audits

Most commonly cited drug GMP deficiencies for 2012-2013

Increase in FDA enforcement actions

Interactive Q&A Session

Who Will Benefit:

Quality Assurance

Quality Control

Manufacturing

Validation

Production

Regulatory Compliance