The Ferer Group Consulting Services

In my professional career, I have consulted with over 50 pharmaceutical and biotechnology companies.  As a consultant, I wear two distinct hats; crisis resolution expert (putting out fires) and project plan, development, and execution expert.

When you are in crisis mode, I can quickly diagnose a problem and develop a strategy for successfully resolving an issue.  I don’t leave until you are back on track and problem-free. Additionally, I leave you with a host of tools for future risk assessment and risk mitigation.

For start ups, I employ my unique skills and vast experience to take you from initial set up, to compliance, to delivery. I get you up and running quickly and efficiently – while meeting all regulatory requirements and providing risk management options to mitigate future problems.

The following lists the consulting services I provide:

• Project Management: managing a project from start up to product delivery
• Operation’s Management: hands-on management of day-to-day operations
• Design Review: perform DR/DQ activities prior to the start of construction
• Validation Consultation: perform risk assessment, identify regulatory requirements, and develop documentation for validation program
• Validation and Quality Master Project Plans: create master plans for small and large scale projects
• Quality Assurance and cGMP Compliance: provide the expertise to ensure that project activities are being performed in compliance with North American and EU regulations
• Supplier/Vendor Audits: includes Quality Systems, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control Systems
• Mock/Pre-Approval Inspection Audits: includes Quality Systems, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control Systems
• SOP/SWI Preparation: create clear, unambiguous, and concise procedures and instructions
• Expert Witness: diverse pharmaceutical background along with track record of success, puts me in the unique position to provide expert witness testimony
• Systems Experience: provide design, operation, maintenance, and control of production utilities, equipment, and systems assistance and expertise

If your goal is to ultimately maintain and expand knowledge in-house, I offer comprehensive training courses designed to transfer my knowledge and wealth of experience to your professionals. 

Training

As a trainer and mentor, I empower individuals to develop their problem solving , risk assessment, and project management skills. By sharing and transferring my knowledge, I enable individuals to benefit from my experience and build upon this foundation to become experts in their field.