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Over the past 12 years, GMP by the Sea has brought attendees the latest and most comprehensive information
needed to stay current in meeting FDA expectations. Today, the pharmaceutical and biotech industries are more
global than ever, with a supply chain spread across the world. We are expecting 17 FDA presenters, 15 of which
are confirmed at press time, plenty of current FDA information that GMP By The Sea is known for.
Plenary sessions highlight current topics from government and industry leaders. The first day focuses on
globalization, with a representative from the United Kingdom’s MHRA and industry experts providing practical
advice on implementing compliance and quality initiatives in international manufacturing environments. The next
day includes presentations on the importance of change control, a “mini-symposium” on FDA’s expectations and
a discussion of applying project management to risk assessment. The conference concludes with compliance and
inspectional updates from FDA.
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