INDIANAPOLIS, Oct. 20, 2015 /PRNewswire/ -- Imagine you receive a Warning Letter from the FDA – you have only 15 days to submit a response. If the FDA finds your response inadequate, you may receive a Consent Decree, which will cost millions of dollars to remediate. Does your company have a plan in place to react to the Warning Letter?
Maetrics, a leading international consulting firm focused on the life sciences sector, provides a step-by-step plan to remediate this situation while educating your company on the procedures and training to prevent receiving a future Warning Letter.
Norman Rabin, Director, Solutions Delivery at Maetrics, and Pamela Furman Forrest, Esq., Partner at King & Spalding, discuss how to effectively respond to FDA 483 observations and warning letters at the 2015 Regulatory Affairs Professional Society (RAPS) Regulatory Convergence, held October 24-28 in Baltimore. This annual event is a multi-day gathering of the global regulatory community that features representatives from the world's leading health authorities including the FDA, EMA and CFDA. The Regulatory Convergence is sponsored by RAPS, the largest global organization of those involved with the regulation of healthcare and related products. Founded in 1976, RAPS helped establish the regulatory profession and continues to support the profession through events such as The Regulatory Convergence.
Norman Rabin comments: "The Regulatory Convergence is the premier event in the promotion of the Life Sciences on a professional level. With the opportunity to meet your peers, including the industry's Director- and VP-level thought leaders, attending this event increases learning, acumen and professionalism. It's a valuable experience well worth the cost. You'll go away with increased knowledge!"
Rabin and Forrest speak Monday, October 26, at 10:15 AM in the exhibit hall with a follow-up session on Tuesday, October 27, at 8:15 AM. For more information regarding Maetrics' presence at The Regulatory Convergence, visit http://www.maetrics.com/events/raps-2015.
Maetrics is a consulting firm exclusively focused on serving the Life Sciences sector. Founded in 1984, Maetrics has evolved to become a global force supporting a significant number of pharmaceutical, biopharmaceutical and medical device firms with their most critical enterprise compliance, performance improvement, risk management, information technology and organisational change management initiatives. Maetrics is currently present in the US (5 offices), the UK and Switzerland.
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