Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain. A fun way to present this serious topic ! Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility. 483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared ? This presentation will use humor to describe: > Why the FDA issues such citations > What is a 483 and what does it look like > What is a Warning letter and what does it look like > What is the difference between a 483 and a Warning Letter > What they mean for your company > How to respond to 483s and Warning Letters to avoid escalation by the FDA > How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters

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Webiar Description:
Areas Covered in the Session :
Who Will Benefit:
The Hitchhiker’s guide to 483s and Warning Letters
Tuesday, May 21, 2013
Duration : 120 Minutes
10:00 AM PDT | 01:00 PM EDT
Speaker | Angela Bazigos
Regulatory Inspections are performed by various agencies to assure that anyone involved in the
lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and
regulations. This affects the entire supply chain.
A fun way to present this serious topic !
Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized
and consumer products your business is regulated by the FDA.
With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the
FDA are perhaps the most intimidating of all events at a regulated facility.
483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a
result of issues uncovered during an Inspection.
In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures.
Can you afford not to be prepared ?
This presentation will use humor to describe:
> Why the FDA issues such citations
> What is a 483 and what does it look like
> What is a Warning letter and what does it look like
> What is the difference between a 483 and a Warning Letter
> What they mean for your company
> How to respond to 483s and Warning Letters to avoid escalation by the FDA
> How to prevent future issues during inspection and avoid future issuances of 483s and Warning
Letters
To register for this webinar please visit our website www.compliancetrainings.com
> Regulatory Affairs professionals
> Quality Managers
> Quality Engineers

2. Speaker Profile:
To register for this webinar please visit our website www.compliancetrainings.com
> CEO
> Regulatory VP
> Quality VPs
> IT VPs
> Small business owners
> GxP
> Consultants
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in life
science. She has received a patent for speeding up software compliance and has applied for patents aimed at
speeding up software compliance and FDA software audits. She has co-authored “Computerized Systems in
Clinical Research” with the FDA, DIA and Academia and teaches classes in project management, computer
systems validation, quality assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society
of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC.
She was recently inducted into Stanford’s Who’s Who for contributions to the Life Sciences industry.