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Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries

Consulting to blood establishments. Offering consulting services, audits, and educational programs for companies and blood establishments seeking FDA compliance and regulatory guidance.

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Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries | tourault.com Reviews
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Consulting to blood establishments. Offering consulting services, audits, and educational programs for companies and blood establishments seeking FDA compliance and regulatory guidance.
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2 blood industry consultant
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5 consulting to blood establishments
6 blood establishment
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8 blood establishment consulting
9 blood bank consulting
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Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries | tourault.com Reviews

https://tourault.com

Consulting to blood establishments. Offering consulting services, audits, and educational programs for companies and blood establishments seeking FDA compliance and regulatory guidance.

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1

Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries

http://www.tourault.com/tourault_faq_response.html

326 Burnside Street Annapolis MD 21403. P) (301) 537-5378 f) (410) 268-7413. 1) How do I respond to FDA Form 483? What is the significance of FDA Form-483? Response to the FDA 483. Who Checks the Checker? 2) How do I respond to a warning letter? 3) How do I respond to a license suspension? 4) How do I perform a 510(k) submission? Response to the FDA 483. By Mary Ann Tourault. The items on the 483 represent the views of the investigator, and it is very important for an establishment to examine the finding...

2

Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries

http://www.tourault.com/tourault_consulting.html

326 Burnside Street Annapolis MD 21403. P) (301) 537-5378 f) (410) 268-7413. As a premier provider of consulting services in the U.S. and Europe, Ms. Tourault consistently delivers the greatest depth of capabilities, expertise, and quality solutions to blood banking, device manufacturing, and pharmaceutical businesses in the following areas:. Good manufacturing practices (GMP) training programs for the blood community. Vendor audits for pharmaceutical manufacturers. Prior Consulting Engagements Include:.

3

Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries

http://www.tourault.com/tourault_faq.html

326 Burnside Street Annapolis MD 21403. P) (301) 537-5378 f) (410) 268-7413. 1) How do I respond to FDA Form 483? What is the significance of FDA Form-483? Response to the FDA 483. Who Checks the Checker? 2) How do I respond to a warning letter? 3) How do I respond to a license suspension? 4) How do I perform a 510(k) submission? What is the significance of FDA Form-483? By Mary Ann Tourault. The guidance states that only significant deviations from the regulations should be placed on the 483 and therein...

4

Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries

http://www.tourault.com/index.html

326 Burnside Street Annapolis MD 21403. P) (301) 537-5378 f) (410) 268-7413. Certifying Your Blood Establishment. Offering consulting services, audits, and educational programs for companies and blood establishments seeking FDA compliance and regulatory guidance, and who wish to leverage their capabilities to the fullest extent. With an American and international client base, Ms. Tourault has. Who Checks the Checker. By Mary Ann Tourault. 1) How do I respond to FDA Form 483? Response to the FDA 483.

5

What is the significance of FDA Form-483?

http://www.tourault.com/article1.htm

What is the significance of FDA Form-483? By Mary Ann Tourault. At the conclusion of many inspections by the Food and Drug Administration (FDA) the investigator issues a list of observations documented on form FDA 483. So what does it mean? FDA written guidance to investigators concerning the 483 may be found in the Investigations Operations Manual (IOM) at www.fda.gov/ora/inspect ref/iom/chaptertext/510part2.html#512. If something happened only one time should that be on the 483? But what if the one tim...

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Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries

326 Burnside Street Annapolis MD 21403. P) (301) 537-5378 f) (410) 268-7413. Certifying Your Blood Establishment. Offering consulting services, audits, and educational programs for companies and blood establishments seeking FDA compliance and regulatory guidance, and who wish to leverage their capabilities to the fullest extent. With an American and international client base, Ms. Tourault has. Who Checks the Checker. By Mary Ann Tourault. 1) How do I respond to FDA Form 483? Response to the FDA 483.

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