Nancy Singer Email & Phone Number

Newport Beach, California, United States

Compliance expert and former Department of Justice litigator for the Food and Drug Administration (FDA). I apply decades of in-depth industry insight and real world experience to train both individuals and groups to employ best documentation practices in their quality management system. My courses are customized to fit your needs and are fast-paced, interactive and easy to follow, regardless of the level of employee. During the high energy session, registrants will not sit back and… Show more Compliance expert and former Department of Justice litigator for the Food and Drug Administration (FDA). I apply decades of in-depth industry insight and real world experience to train both individuals and groups to employ best documentation practices in their quality management system. My courses are customized to fit your needs and are fast-paced, interactive and easy to follow, regardless of the level of employee. During the high energy session, registrants will not sit back and passively listen to series of boring lectures. Rather they will be divided into teams and through case studies, real life examples and exercises, they will discover how to ensure that their written correspondence reflects the depth of the company's culture of compliance. Some of the areas I will cover include who can be held criminally liable under the Federal Food, Drug, and Cosmetic Act; what FDA investigators look for when reviewing documents; the risks of leaving blanks in required records; and how to write informative documents that don't make you or your firm a target for investigation. I also cover how to document your firm's risk management activities; the types of information you or your employees should never include in documents; and the bad words that will attract the attention of prosecutors. I will teach you and your employees how to write a memo that will be read and acted upon and how to build a program to avoid dangerous documents. They will be motivated to create correspondence that, if subpoenaed, will demonstrate your firm’s commitment to quality and regulatory compliance… instead of embarrassing surprises. Show less

Alexandria, Virginia, United States

I was the general counsel of an international OTC drug and medical device company that provided innovative products for new mothers. I was responsible for providing advice on contracts, regulatory/legal/compliance matters related to new product clearance, postmarket surveillance, advertising and promotion, and quality assurance issues.

Washington, District Of Columbia, United States

I was the founder and the Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provided training on FDA and CMS regulatory requirements. I served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In my role as Special Counsel, I was a member of the FDA industry working group that evaluated and proposed reforms to the FDA inspectional process. I represented the device industry on the working group… Show more I was the founder and the Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provided training on FDA and CMS regulatory requirements. I served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In my role as Special Counsel, I was a member of the FDA industry working group that evaluated and proposed reforms to the FDA inspectional process. I represented the device industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). I served as the industry spokesperson on the educational programs that taught Quality System Inspection Technique to representatives of the FDA and the medical device industry. Show less

Washington, District Of Columbia, United States

I managed a $3 million educational association that sponsored conferences, assisted in curriculum development for law school courses, and provided scholarships, fellowships and grants to law students.

Washington, District Of Columbia, United States

Provided legal advice and counsel to drug, device and food manufacturers.

Washington, District Of Columbia, United States

Undefeated Prosecutor

Bachelor Of Science - Bs, Psychology

Jd

Llm