www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Life sciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: Counterfeit medicine is a fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and are frequently harmful to consumer health up to and including death of a patient. Counterfeit drugs are a $75 Billion / year business with phenomenal profits. Counterfeit medicine may be either a fake drug or a fake ingredient that finds its way into the manufacture of a legitimate medicine.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you be Attending? Counterfeiting has significant economic consequences. In reality, it "hijacks" the brand and infringes the patent and trademark rights of legitimate pharmaceutical manufacturers. Additionally, counterfeiters take full advantage of the fact that someone else paid the upfront money for research and development expenses; all counterfeiters have to do is to copy the appearance of the product. Even if a drug is manufactured in the United States or by an international reputable firm, many of the raw ingredients of a drug are often imported from countries that have loose regulatory oversight. This was the case with Heparin a few years ago, where a counterfeit ingredient in the drug caused the death of 80 people.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation: The objectives of the presentation are : What is a counterfeit medicine / ingredient How pervasive is the problem What risks are associated with counterfeit medicines / ingredients What are the economic consequences of counterfeiting How do counterfeit medicines / ingredients enter the United States and our supply chain Who profits from counterfeit medicine/ ingredients How to purchase medicines / ingredients to avoid counterfeits How can you tell if you receive a counterfeit What can you do to address the problem www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can be Benefited? Doctors Nurses Regulatory Affairs Quality Assurance Manufacturing Regulatory Authority Inspectors Consumers
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works? Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf formate will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Get certification of attendance.
Recorded Session - How it works? A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf formate will be mailed to you Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com