Carol Cooper

Carol Cooper Email and Phone Number

Principal Consultant @ CM Cooper and Associates
Libertyville, IL, US
Carol Cooper's Location
Libertyville, Illinois, United States, United States
Carol Cooper's Contact Details

Carol Cooper personal email

n/a
About Carol Cooper

CM Cooper and AssociatesPrincipalRegulatory and Clinical Consultant specializing in the regulated Healthcare Industries- Biologics, Cosmetics, CDx, Diagnostics, Dietary Supplements, Medical Devices, OTCs Devices/Pharmaceuticals, and IVD EUAs.There are several specific areas worth noting as a consultant group.First Area of Expertise: Regulatory Reviews of Promotional LabelingMLR or PRC member for biologics, cosmetics, CDx, dietary supplements, drugs, IVDs, medical devices, OTCs.Additional Area of Expertise: Regulatory Consultant in Strategy and requirements for: Annual reports, CLIA Waivers, IDE, 510(k) and PMA submissions - CTD/TF - DOCs - Labeling - Registrations and Listings - Strategy

Carol Cooper's Current Company Details
CM Cooper and Associates

Cm Cooper And Associates

View
Principal Consultant
Libertyville, IL, US
Website:
raps.org
Employees:
130
Carol Cooper Work Experience Details
  • Cm Cooper And Associates
    Principal Consultant
    Cm Cooper And Associates
    Libertyville, Il, Us
  • Regulatory Affairs Professionals Society (Raps)
    Raps Board Member
    Regulatory Affairs Professionals Society (Raps) Jan 2019 - Present
    Rockville, Md
    View
  • Cm Cooper And Associates
    Principal Consultant
    Cm Cooper And Associates Jun 2014 - Present
    Greater Chicago Area
  • Self-Employed
    Regulatory Expert In Advertising And Promotion
    Self-Employed May 2009 - Present
  • Raps - Chicago Chapter
    Chapter Chair Or Co-Chair
    Raps - Chicago Chapter 2006 - Dec 2018
  • Baxter Healthcare
    Associate Director - Advertising And Promotion
    Baxter Healthcare Dec 2009 - Dec 2013
    Deerfield And Round Lake
    View
  • Abbott Labs - Add
    Manager, Regulatory Affairs
    Abbott Labs - Add May 2006 - Dec 2009
    Abbott Park, Il
    Manager of Advertising and Promotion and Scientific Review.Submitted and interfaced with the FDA on PMA and 510(k)s. and portions of DMFs, INDs, IDEs and BLA submissions.
  • Abbott Diagnostics Business
    Manager Regulatory Affairs
    Abbott Diagnostics Business 1990 - 2008
    View
  • Abbott Labs
    Regulatory Manager
    Abbott Labs 2006 - 2007

Carol Cooper Skills

Fda Regulatory Affairs Medical Devices Pharmaceutical Industry Gmp Regulatory Submissions Validation Biotechnology Ind Regulatory Requirements Life Sciences Quality System V&v Change Control Cross Functional Team Leadership 21 Cfr Part 11 Iso 13485 Biologics Glp Clinical Trials Biopharmaceuticals Pma Pharmacovigilance Immunoassays Clinical Development Design Control Sop Product Development Strategy Immunology Gcp Cro Clinical Research Drug Development Infectious Diseases Lifesciences Pharmaceutics Commercialization Regulatory Strategy Assay Development 510 K Quality Systems Compliance Cgmp Diagnostics Clinical Qsr Pharmaceuticals In Vitro Ce Marking

Carol Cooper Education Details

Frequently Asked Questions about Carol Cooper

What company does Carol Cooper work for?

Carol Cooper works for Cm Cooper And Associates

What is Carol Cooper's role at the current company?

Carol Cooper's current role is Principal Consultant.

What is Carol Cooper's email address?

Carol Cooper's email address is cc****@****bal.net

What schools did Carol Cooper attend?

Carol Cooper attended Temple University, University Of Wisconsin-Madison.

What are some of Carol Cooper's interests?

Carol Cooper has interest in Environment.

What skills is Carol Cooper known for?

Carol Cooper has skills like Fda, Regulatory Affairs, Medical Devices, Pharmaceutical Industry, Gmp, Regulatory Submissions, Validation, Biotechnology, Ind, Regulatory Requirements, Life Sciences, Quality System.

Who are Carol Cooper's colleagues?

Carol Cooper's colleagues are Olga De La Rosa, Julie A. Gordon, Liza Liza, Vinayak Kangale, Johnas Miguel Beltran, Kajal Patel, Holly L. Dotson.

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