John Brda Email and Phone Number
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Over 35+ years of Regulatory and Quality experience dealing in the areas of Drug (Over-the-Counter and sterile Rx), Medical Device and Biological Regulatory Affairs. In this time period, much of the experience has been with two Fortune 100 Companies: Baxter HealthCare and Cardinal Health. In the last 10 years, the majority has been in obtaining approval of a new drug in the Europe Union and Canada as well as most recently, working with the FDA on an Over-The-Counter Drug including all advertising and promotional review and approval.A wealth of expertise with FDA while dealing with the Chicago District Office. Personally hosted and been the point person on over 40 General and Pre-Approval Inspections. Many of these without at 483 citation issued. This has been from 1995 to the present keeping current with both Drug and Medical Device Inspectors.Specialties: OTC Drug Development, GMP Inspections, Advertising review, International experience and FDA Drug and Device applications. Ability to work well in diverse disciplines to meet and surpass Regulatory deadlines.
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Pharmaceutical CompanyPharmaceutical Manufacturer - Mundelein -
Independant Regulatory Affairs ConsultantPharmaceutical Company Oct 2013 - PresentPk
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Regulatory Affairs ManagerSage Products Incorporated Dec 2005 - Jun 2013•Managed a staff of Regulatory Affairs Professionals as well as complaint handling to facilitate the development of new NDA product (Patient Preoperative Skin preparation) as well as the continuation of existing products.•Directed the strategy of line extension initiatives for approved Over the Counter (OTC) drug and device products focusing on regulatory strategies for new indications, additional claims and labeling revisions.•Provided guidance for all advertising and promotion of marketed products for all personnel bathing, oral hygiene and incontinence products.•Point person for all FDA, MHRA, and ISO Inspections.
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Associate Director RaAlp/Cardinal Health 1994 - 2005• Regained GMP Compliance following several Warning Letters regarding Quality System and Regulatory requirements.• Oversaw the development and execution of U.S. strategy for all CMC submissions for all ANDA and NDA Agency submissions for Cardinal Health as well as all Contract Customers.• Managed a staff of seven Regulatory as well as Documentation Professionals to facilitate the development of new products (Glaucoma Drugs and lines of Asthmatic Inhalation Drugs) as well as the continuation of existing products.• Directed the strategy of line extension initiatives for approved drug products focusing on regulatory strategies for new indications, additional claims and labeling revisions.• Liaison and Company lead for over 25 Contract Customer annual audits as well as all FDA, MCA and ISO Investigators.• Significantly reduced the quantity and level of deviations through the use of process improvements and better communication.
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Manager Of Regulatory AffairsSchering-Plough Jan 1990 - Jan 1994Developed and executed the worldwide strategy for rapid approval and registration of new products such as regular and disposable Contact Lenses.Obtained approval for the first disposable colored Contact Lens in Japan and Australia.Conducted three successful Clinical Studies for a disposable and regular colored Contact Lenses as well as a Multi-Purpose Contact Lens Cleaning Solution.Provided guidance for all advertising and promotion of marketed products for all Ocular Solutions and Contact Lenses.Successfully wrote and executed IND’s and PMAA’s for several lines of Class III Hydrophilic Contact Lenses.Managed all Customer Complaint areas as well as documentation requirements for FDA required communication.
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Senior Compliance AuditorSchering-Plough Jan 1988 - Jan 1990Assessed the Quality and Regulatory risks for twenty of Baxter’s Divisions with combined sales of more than $3 billion.Developed worldwide training manuals and presented workshops to all levels of facility personnel to facilitate the Divisional Auditors' understanding and assessing of the GMP’s.Negotiated and developed corrective action plans for three pharmaceutical manufacturing facilities previously cited by the Agency for Warning Letters and GMP violations.
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Regulatory AffairsBaxter Healthcare 1978 - 1994Deerfield, Illinois, UsInitially out of College, I was a Senior Physiologist in the Fenwal Division of Baster. In this position, I was responsible for the development of Drugs and Devices for the storage and collection of whole blood.Throughout the majority of my career at Baxter it was in Regulatory Affairs Management in Drugs and Medical Devices. -
Regulatory Affairs AdministratorBaster Healthcare Jan 1982 - Jan 1988Attained timely approval of several NDA’s and numerous CDER Supplements and over 40 Medical Device Submissions. Received quick Agency approval with no time constraints of two international Baxter facilities and three domestic facilities to develop Pharmaceutical Products.Experienced with Class I and II Medical devices and extensive experience with the General Hospital and Personal Use Divisions within the FDA.
John Brda Skills
John Brda Education Details
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Roosevelt UniversityManagement -
University Of South FloridaNatural Science
Frequently Asked Questions about John Brda
What company does John Brda work for?
John Brda works for Pharmaceutical Company
What is John Brda's role at the current company?
John Brda's current role is Independant Regulatory Affairs Consultant (Retired May 3, 2018).
What is John Brda's email address?
John Brda's email address is jb****@****cts.com
What is John Brda's direct phone number?
John Brda's direct phone number is (815)-455*****
What schools did John Brda attend?
John Brda attended Roosevelt University, University Of South Florida.
What are some of John Brda's interests?
John Brda has interest in Social Services, Children, Environment, Education, Science And Technology.
What skills is John Brda known for?
John Brda has skills like Fda, Regulatory Affairs, Gmp, Medical Devices, Pharmaceutical Industry, Quality System, Regulatory Submissions, Regulatory Requirements, Capa, Change Control, 21 Cfr Part 11, Quality Assurance.
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