John Brda Email & Phone Number

Lake Villa, Il, Us

Pharmaceutical Manufacturer - Mundelein

Pk

•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.

• 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.

Developed 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.

Assessed 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.

Deerfield, Illinois, Us

Initially 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.

Attained 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.

Mba, Management

Ba, Natural Science