Justin Pennington

Justin G. Pennington, RAC

92 S Main St #102, Memphis, TN 38103

jpennington@ppspharmrx.com

 

REGULATORY AFFAIRS, QUALITY and COMPLIANCE PROFESSIONAL

Highly driven and energetic professional with demonstrated proficiencies directing top-level regulatory and quality initiatives within the pharmaceutical and medical device industries.

 

PROFESSIONAL PROFILE

• Compliance-driven, professional with an established background developing, commercializing and distributing pharmaceuticals and medical devices within domestic and international markets.
• Proactive self-starter with a track record of initiative, personal ownership of work, and a reputation for removing obstacles and making things happen.
• Inquisitive and analytical thinker with a demonstrated ability to scrutinize and achieve regulatory objectives. 
• Strong leader, who effectively prioritizes tasks, motivates others and directs top-level regulatory initiatives.     
• Excellent interpersonal communicator, presenter, and implementer; skilled in challenging conventional practices, facilitating appropriate change and producing desired results. 

AREAS OF EXPERTISE

• FDA, DEA, EMEA and State Regulations
• Continuous Process Improvement / Change Control
• New Product Development, Registration, and Listing
• Document Control & Compliance
• Product Labeling/Marketing Compliance (DDMAC, etc.)
• Employee Training & Teamwork Facilitation
• PDMA & Pedigree Compliance, etc.
• FDA/DEA Registration and State Licensing
• FDA, DEA, VAWD and State Reporting
• Import / Export Regulations
• Full Product Life-Cycle Documentation
• Product Recalls, Complaints and ADR Reporting
• FDA, DEA, VAWD and State Audit Management
• SOP Development, Review & Implementation
• FDA, DEA, VAWD State & Vendor Negotiations
• Regulatory Research and Legislative Monitoring
• Clinical Trial Compliance and Auditing
• Regulatory Strategy and Presentations
• Corrective and Preventative Action (CAPA)
• Crisis Management Programs and Resolution Strategies
• Regulatory Strategy and Risk/Benefit Analysis
• Theft/Loss Investigations and Reporting
• Regulatory/Quality Policy and Procedures
• Suspicious Order Monitoring Systems and Reporting
• Vendor Screening and Auditing
• Facility/Personnel Security and Access Restrictions
• GMP, GCP, GLP and GDP compliance & Auditing
• Due Diligence Screening and Monitoring of VendorS
• Quality Management Systems – ISO 13458 / ISO 9001
• Sales Rep Auditing and Inventory Accountability

PROFESSIONAL EXPERIENCE 

Principal Consultant - Regulatory & Quality – Pennington Pharmaceutical Services LLC, Memphis, TN – March 2010 – Present

Manager, Regulatory Compliance - DDN, Memphis, TN – January 2008 - March 2010

Manager, Regulatory Affairs, Quality, and Auditing - Cypress Pharmaceutical, Inc., Madison, MS – August 2006 - December 2007

Manager, Regulatory Affairs, Quality, and Auditing - Hawthorn Pharmaceuticals, Inc., Madison, MS – August 2006 - December 2007

Analyst – Eurofins Scientific, Memphis, TN – June 2005 - July 2006

 

SPEAKING ENGAGEMENTS

• State Licensing and Drug Distribution Regulations. Fifth Annual Porzio Compliance Forum, Basking Ridge, NJ, October 2010.

CERTIFICATION(S)

• Regulatory Affairs Certification (RAC)

EDUCATION

• Bachelor of Arts in Biochemistry, University of Mississippi 
• Bachelor of Arts in Psychology, University of Mississippi

Justin Pennington - LookupPage

My Company Website

My Linkedin Profile

Consulting Services.pdf

Consulting Service Request Form.pdf