About Us

• A seasoned professional with extensive experience in FDA regulatory compliance, validation, project management, and business analysis.
  
  
• Experienced in applying FDA and other regulations to the development, implementation, and support of computer systems supporting regulated business processes.
  
  
• Experienced in the definition, management, and implementation of significant technology-focused projects and establishing standard quality and validation practices. 
  
  
• Manages, directs, and interfaces with clients to successfully implement technology and process solutions to meet business and regulatory requirements. 
  
  
• Excellent communication and leadership skills to build effective teams and deliver critical projects. 
  
  
• Experienced in managing projects with an emphasis on re-engineering to gain operational efficiency, support new business strategies, and achieve regulatory compliance. 
  
  
• Experienced assessing and auditing computer systems for compliance, establishing remediation plans, developing processes and procedures, and preparing and reviewing validation documentation. 
  
  
• Experienced in custom software development, implementation of commercial off-the-shelf (COTS) applications, and training staff in project management and compliance methodologies. 
  
  
• Expertise in both the Project Management Life Cycle and the System Development Life Cycle. Certified Project Management Professional (PMP®).

Experienced in the following:

– Understanding, applying, and objectively evaluating the principles of GMP requirements for computerized systems used in manufacturing, processing, packing, holding, and distribution of drugs.

– Conducting GMP inspections of computerized systems and ensuring that the Quality Management System policies, procedures, standards, and controls are designed to assure the adequate and sustainable compliance of computerized systems and comply with applicable laws, regulations, and, when necessary, a consent decree.

– Assessing the organizations, roles, responsibilities, resources, qualifications, and training that support the qualification, validation, technical support, operation, and quality oversight of computer systems.

– Assessing programs for risk-based qualification, validation, remediation, performance monitoring, and change management.

– Developing remediation plans and ensuring that remediation activities for the Quality Management.

– System and individual computer systems comply with applicable laws and regulations.

– Inspection of GMP activities for computer systems used in the manufacturing, processing, packing, holding, and distribution of drugs.

– Preparing audit reports of inspections outlining findings and the state of compliance with regulatory requirements.

– Assessing controls over computerized laboratory instrumentation and data acquisition, processing, evaluation, and reporting.

Experienced project management is a key ingredient in the successful outcome of any project. Each project is a unique activity and generates a unique deliverable. Each project that is undertaken must address issues of scope, time, cost, and quality. Projects with regulatory impact may have to deal with computer system validation for FDA compliance or Sarbanes-Oxley compliance, for example. 

Each new initiative must address the following: What are the goals of the project? Who is responsible for what? Who has authority? How do we communicate to stay informed? How do we manage change? How do we ensure compliance? The unique nature of projects means that these and other questions must be addressed as each new project is undertaken. 

An experienced project manager employing the proper tools and techniques can help ensure that your project stays on track. Our project management services are provided by a PMP® Certified Professional with years of practical project and management experience.