David Beroll

About David Beroll

Validation, Quality Assurance, Process, Project, Equipment and CommissioningEngineering Professional over 25 years of industry experience in:Pharmaceuticals, BioPharmaceuticals, Combination Products and Medical Deviceswth a knowledge and understanding to apply- Current drug and medical device regulations from the FDA and foreign regulatory bodies - Industry guidelines and standards including ISPE, PDA, ASME, ISO and ANSI - US and Foreign Pharmacopeial specifications and methodsand the ability to- Effectively and efficiently communicate and present ideas, opinions and findings orally and in writing - Successfully interact with all levels of management, professionals, vendors, contractors and tradespeople - Use a structured approach (RCA) to identify issues, actual or potential problems and adverse events - Determine, document and apply corrective and preventative actions (CAPA)- Self-manage time and tasks to maximize productivity and meet or exceed goals and deadlines

Experience

1. Principal Consultant

   CAI

   Jan 2020 — Present · TX, US

Education

• University of Massachusetts Amherst

  BSME, Mechanical Engineering

  1986 — 1990

Skills

• Change Control
• Six Sigma
• Gxp
• Equipment Qualification
• Quality Auditing
• Aseptic Processing
• Pharmaceutics
• Iso 14971
• Quality Assurance
• Design Control
• Sterilization
• Regulatory Affairs
• Lifesciences
• Analytical Chemistry
• Cleaning Validation
• Trackwise
• Manufacturing
• Cgmp Practices
• Calibration
• Glp
• Biopharmaceuticals
• Chromatography
• Cgmp Manufacturing
• Quality System
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Document Management
• Process Simulation
• Validation
• Deviations
• Technology Transfer
• 21 Cfr Part 11
• Root Cause Analysis
• R&D
• Engineering
• Quality Control
• Gmp
• Gamp