(St. Petersburg, FL – 11/12/2009) Those companies involved in pharmaceutical, medical device, diagnostic, biopharmaceutical, dietary supplement, cosmetic, and even food manufacturing and distribution need to prepare themselves for the Food and Drug Administration's (FDA) new focus on fast acting and swift regulatory action.

 

FDA's Commissioner, Margaret A. Hamburg, M.D., recently announced the agency's new commitment 'to prevent harm to the American people' through aggressive and effective enforcement of FDA laws and regulations. Hamburg stated that FDA's new focus will be to act quickly, strategically, and to remain visible to the American public and industry. This is a clear message to industry that it needs to be ready for FDA inspections now!

While FDA regulated firms may not have been audited recently, may not have had any serious FDA issues in the past, or may never have been inspected by FDA ever, now is the time to be prepared as FDA inspections can quickly result in thousands and even millions of dollars lost spent in order to come into compliance.

One way to make sure your firm is ready for an inspection is to know how and when to respond to FDA once an inspection is complete and FDA submits its list of observations (i.e. a Form 483) and is many times the case, a Warning Letter. A well written response can many times avoid further regulatory action if it is written within specific time frames and includes the language that FDA is expecting to see.

While many organizations immediately hire a law firm to 'do battle' with FDA and its observations, this is often a very bad idea. Simply stated, FDA typically has more lawyers, more experts, more time, more money, and will most of the time 'win the battle' and more times than not, will win the war.

So, how can you be sure that your firm is ready to respond to FDA once the agency walks in the door unannounced? You can hire a consultant or law firm to provide general advice for an average of $10,000 per day. As a cost-effective alternative, you can prepare yourself for FREE!



Advanced Biomedical Consulting (ABC), LLC (www.abcforfda.com), one of the world's leading consulting firms in the FDA regulated industries and renowned experts in responding to FDA Form 483 observations, Warning Letters, and untitled regulatory compliance letters, is joining forces with the American Health Sciences Institute. (www.ahs-institute.com), to provide a ONETIME ONLY one hour training seminar absolutely FREE! This seminar will take place over the web (i.e. a webinar) on Friday, December 18, 2009, at 12:00 pm EST.

This 100% FREE seminar will address the following topics and current methodologies that you and your firm will need to know before the agency shows up to your door looking to implement the new compliance focus:

• Components of FDA 483's and Warning Letters

Space is limited for this training session and is 50% full already. So, sign up today by going to http://www.ahs-institute.com/webseminars.php, where you will also find additional details on this FREE seminar, Responding to FDA 483s and Warning Letters: Developing Your Plan of Action for a Positive Outcome.

 

ABC provides a wide range of consulting services to industries associated with the manufacturing and distribution of Food and Drug Administration (FDA) regulated products. With a diversified workforce made up of published technical and regulatory experts in the pharmaceutical, medical device/diagnostic, biopharmaceutical, cosmetic, food/seafood, and animal feed industries, ABC can provide cost-effective solutions to nearly all issues encountered in FDA regulated industries, including but not limited to the following popular services:

The American Health Sciences Institute (AHSI) is a national leader in the delivery of skills-based training solutions to professionals in the drug discovery & development, health care, and regulatory environments. AHSI is a division of ASPE, Inc., an international training provider headquartered in Cary, North Carolina with hundreds of educational offerings in the fields of technology, management skills, business and finance, in addition to health care and life sciences.