Rac Rita Hoffman

FAQ About Rac Rita Hoffman

• What is Rac Rita Hoffman's address?

  Rac Rita Hoffman is located at
  Baltimore, Maryland, United States

• What is Rac Rita Hoffman's job title?

  Rac Rita Hoffman is a
  Over 38 years with FDA in the area of compliance. For the past 11 years devoted to industry training and consulting in the area of compliance with regulations and response to FDA, recall, Complaint Handing, MDR/eMDR management, Field Safety Alerts for drug products and FDA remediation of enforcement actions primarily focused in medical devices, pharmaceuticals and combination products and Pharmacy Compounding. -Branch Chief, Recalls – 3 yrs., CDRH -Regulatory Project Manager – 4 yrs., (CDER) -Acting Ombudsman– 6 mo., CDER -Jurisdictional Officer/Compliance Officer, 18 yrs., CDER -Consumer Safety Officer– 4.5 yrs., Ctr for Vet Med -Policy Analyst - 7 yrs., Office of the Commissioner and Office of Regulatory Affairs (ORA) Additional Experience: -RAPS--Baltimore/Washington Chapter Leader 4 yrs. -FDA Small Business Liaisons 10 yrs. FDA Consultant and Training Specialist – 11 yrs. Extensive knowledge and experience in the application of FDA law, regulations, and policy, particularly as it relates to compliance and enforcement programs and strategy including the following: -Legal authority of 21 CFR Parts 7 & 806, 803 and 820 FD&C Act, -Develop and evaluate CAPA’s -Implement effective recalls -strategy, notifications, effectiveness checks & audit program -Assist on Market Withdrawal/Safety Alerts for Devices/Drugs -Provide assistance in the development of procedures & executing Health Hazard Analysis as related to recall decision making -Prepare responses to FDA 483’s and warning letters -Initiating and conducting successful interactions w/ FDA -Expert Trainer - In-house Industry training on FDA regulations -Webinar presentations on Recalls, MDR Reporting and Complaint Handling -Lecture and Seminars on FDA related compliance issues -Consultation with Industry Management for regulatory matters -Interactions with FDA Compliance personnel -Provide guidance to Law Firms on FDA related compliance issues -Expert in all Areas of Post-Marketing, including MDR, Complaint Handing and Recalls Nsf Life Sciences

• What industry does Rac Rita Hoffman currently work in?

  Rac Rita Hoffman currently works in the
  Nsf Life Sciences

• What is Rac Rita Hoffman's area of expertise?

  Rac Rita Hoffman specializes in
  Over 38 years with FDA in the area of compliance. For the past 11 years devoted to industry training and consulting in the area of compliance with regulations and response to FDA, recall, Complaint Handing, MDR/eMDR management, Field Safety Alerts for drug products and FDA remediation of enforcement actions primarily focused in medical devices, pharmaceuticals and combination products and Pharmacy Compounding. -Branch Chief, Recalls – 3 yrs., CDRH -Regulatory Project Manager – 4 yrs., (CDER) -Acting Ombudsman– 6 mo., CDER -Jurisdictional Officer/Compliance Officer, 18 yrs., CDER -Consumer Safety Officer– 4.5 yrs., Ctr for Vet Med -Policy Analyst - 7 yrs., Office of the Commissioner and Office of Regulatory Affairs (ORA) Additional Experience: -RAPS--Baltimore/Washington Chapter Leader 4 yrs. -FDA Small Business Liaisons 10 yrs. FDA Consultant and Training Specialist – 11 yrs. Extensive knowledge and experience in the application of FDA law, regulations, and policy, particularly as it relates to compliance and enforcement programs and strategy including the following: -Legal authority of 21 CFR Parts 7 & 806, 803 and 820 FD&C Act, -Develop and evaluate CAPA’s -Implement effective recalls -strategy, notifications, effectiveness checks & audit program -Assist on Market Withdrawal/Safety Alerts for Devices/Drugs -Provide assistance in the development of procedures & executing Health Hazard Analysis as related to recall decision making -Prepare responses to FDA 483’s and warning letters -Initiating and conducting successful interactions w/ FDA -Expert Trainer - In-house Industry training on FDA regulations -Webinar presentations on Recalls, MDR Reporting and Complaint Handling -Lecture and Seminars on FDA related compliance issues -Consultation with Industry Management for regulatory matters -Interactions with FDA Compliance personnel -Provide guidance to Law Firms on FDA related compliance issues -Expert in all Areas of Post-Marketing, including MDR, Complaint Handing and Recalls

• Which languages does Rac Rita Hoffman speak? 

  Rac Rita Hoffman speaks the following languages:
  No languages available.

• Which industries has Rac Rita Hoffman previously worked in?   

  Rac Rita Hoffman has prior experience in the following industries:
  Enhanced Compliance , Enhanced Compliance , The Fda , Complianceonline , Noblett And Rueland , Barile And Associates , Fda , Regulatory Affairs Professionals Society , Fda

• What is Rac Rita Hoffman’s work experience?  

  Rac Rita Hoffman has the following professional experience:
  Nsf Life Sciences , Enhanced Compliance , Enhanced Compliance , The Fda , Regs And Recall Strategies , Regs And Recall Strategies , Complianceonline , Noblett And Rueland , Barile And Associates , Fda , Regulatory Affairs Professionals Society , Fda .

• How can I find Rac Rita Hoffman on LinkedIn?  

  You can view Rac Rita Hoffman’s
  LinkedIn profile at LinkedIn URL.

• What are Rac Rita Hoffman’s work email addresses?  

  Rac Rita Hoffman’s work email addresses are
  [email protected] .

• What company does Rac Rita Hoffman work for?  

  Rac Rita Hoffman works at
  Nsf Life Sciences