GDI’s Committment to GMP Compliance

Through stringent contamination control programs and adherence to cGMP protocols, GDI ensures the integrity of your production environment.  

By minimizing risk of product contamination and eliminating cross-contamination, we safeguard not only the quality of your products but also comply with regulatory standards, making GDI your trusted partner in maintaining the highest standards of cleanliness and safety. 

GDI's GMP Center of Excellence     

GMP Academy

GMP Academy

GDI's GMP Academy offers comprehensive training for both frontline staff and management on clean room behavior and contamination control guidelines.

Our academy also develops and administers a cutting-edge Learning Management System (LMS) to streamline and enhance the training process.
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Certifications

Certifications

All GMP employees undergo in-house training and certification through the GMP Academy.

GMP management also receive certification from the prestigious Bio Pharma Institute. 
 
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Quality Control and Quality Assurance 

Quality Control and Quality Assurance 

Our GMP Quality Program includes comprehensive SOP reviews, support, and advisory services for supplier qualification programs, and assistance with regulatory approvals.

The GDP Campaign focuses on collecting data documentation practices and KPI measurements to retain top-performing employees. We also offer customizable corrective action plans for clients to prevent deviations.
We support the GMP internal audit program by scheduling and conducting thorough internal audits. Additionally, we review and approve quality events such as deviations, OOS investigations, change controls, and CAPA.

Other duties are performed as assigned to ensure the highest standards of quality control and assurance.
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Why Choose GDI
for GMP and Controlled Environment Services

  • Comprehensive Services: Tailored offerings specifically for life sciences and manufacturing sectors.
  • Deep Expertise: Extensive knowledge and application of cutting-edge technology.
  • Advanced Training: Continuous development in contamination and particle control protocols.
  • State-of-the-Art Technology: Technicians equipped with the latest in cleaning technology and practices.
  • Regulatory Compliance: Ensures facilities meet and exceed stringent regulatory standards.
  • Customized Solutions: Services tailored to meet the unique needs of each client, focusing on GMP cleaning excellence.
GMP and Controlled environment services

SERVICES

GDI offers a broad array of GMP services designed to maintain the integrity of your controlled environments: 

Meet Our Team

Life Sciences Division Team and GMP Subject Matter Experts

Mabia Tavares

GMP SME Business Development

Mike Cadotte

Vice President of Quality Assurance Business Services Group - US 

Jonathan Sauze

Vice President of Risk & Safety

Yogi-Kale

Yogi Kale

Head of GMP vertical

Mabia Tavares is a master of excellence in the field of Good Manufacturing Practices (GMP) and contamination control. As a distinguished GxP Subject Matter Expert (SME) with a profound background in cGxP facilities services management, compliance, and training, her career is a testament to unwavering dedication and expertise. With extensive experience across the Biopharmaceutical and Semiconductor industries, Mabia has honed her skills in the crucial areas of GMP, Client and Contract Management, Life Science contamination control programs, and ensuring GMP/ISO compliance. Her ability to manage multidisciplinary project teams and her proficiency in languages, including Portuguese and Spanish, further exemplify her versatile skill set. 

Mike Cadotte has 30 years of experience with GDI and is a systems process professional who developed, installed, and has maintained GDI’s various quality certifications including ISO 9001, ISO 14001, and CIMS standards. Mike’s dedication to process control and total quality management has been a decades long pursuit at GDI. Mike oversees all quality programs for the US and leads GDI’s global ESG effort as well. Mike has developed GDI’s subject matter expert team initiatives that includes the GxP-Life Sciences Subject Matter Expert Team with the direct intent to not only maintain solid process, procedure, and quality service delivery controls in that vertical but continue to build, learn, and grow GDI’s understanding of GxP-Life Sciences so as to continually maintain the highest level of excellence in the industry. 

Jonathan Sauze has 16 years of combined hands-on and managerial experience in Health, Safety, Security, Environmental, Quality, and Risk Management in manufacturing, transportation, and facility services. Jonathan is a Certified Safety Professional (CSP), and Lead Auditor for ISO 45001:2018 and ISO 14001:2015. Areas of expertise include Environmental & Safety Management, Program/Project Management, Inspections & Auditing, OSHA/ISO Standards & Compliance, Root Cause Analysis, Behavior-Based Safety, Safety Management Systems, Continuous Improvement, Risk Assessment, Hazardous Waste Management, Partnership Management, Strategy Planning, and claim Management. As VP of Risk & Safety for GDI US, Jonathan leads the development and execution of H&S initiatives in partnership with the field operation team to promote a workplace safety culture. This includes developing, implementing, and coordinating H&S programs and policies to ensure corporate goals attainment as well as compliance with all applicable regulations. 

Yogi Kale is a seasoned professional with 33 years of rich, intercontinental experience in facilities management and the hospitality sector, currently serving as the Senior Vice President at GDI Integrated Facility Services. With a deep-rooted passion for clean-tech innovation and operational excellence, Yogi leads the Western Region in organic growth, fiscal performance, customer retention, and enhancing employee experiences. His expertise extends across Integrated Facility Management (IFM), Environmental, Social, and Governance (ESG), Good Manufacturing Practice (GMP), and other compliance standards. 

Yogi has played a pivotal role in elevating GMP cleaning services to meet stringent regulatory standards, crucial for industries such as pharmaceuticals, food, and semiconductor manufacturing. He has managed datacenter cleaning protocols and the development of cleaning standards compliant with FDA regulations. A strong advocate for continuous improvement and ethical integrity, Yogi drives business growth and client satisfaction through innovative technology platforms, strategic planning, and fostering multicultural relationships. Under his leadership, clients experience elevated standards of cleanliness and sustainability, ensuring GDI remains at the forefront of the facility services industry. 

Why Trust GDI with Your GMP and Controlled Environment

Under our team’s expertise, GDI Integrated Facility Services transcends the ordinary, offering unparalleled GMP cleaning and contamination control services.

Our innovative approach to problem-solving, dedication to continuous improvement, and proven leadership in executing complex projects make GDI a valuable asset to any organization seeking GMP compliance.

Choosing GDI means partnering with a team that is not just proficient in GMP standards but is also committed to elevating the standards of cleanliness and compliance in your facilities.

 

Trust in GDI to guide your operations to excellence in GMP compliance and contamination control.

GMP Controlled Environment

Proven Leadership in GMP Cleaning and Contamination Control

  • GDI Leadership: Developed GxP contamination control programs for top organizations such as Catalent, Takeda, and Thermo Fisher.  
  • Project Execution: Spearheaded the facility start-up at a new $180M viral vector manufacturing facility, demonstrating exceptional project leadership and execution skills. 

Staying at the Forefront of Industry Standards

  • Commitment to Excellence: GDI stays current with the latest GMP regulations, cleaning techniques, and industry standards. 
  • Professional Engagement: Active involvement in organizations like PDA, ISPE, LULAC, Interfex, and MassBio. 
  • Certifications: Maintains Bio Pharma Institute certification for GMP cleaning, ensuring adherence to the latest FDA guidelines and industry innovations. 

Mastering Challenges with Innovative Solutions

  • Innovative Training Solutions Established a GMP academy to address hiring and training challenges in regions lacking qualified personnel, enhancing GMP and GDP practices significantly across GDI. 

Philosophy on Training and Mentoring

  • Training Excellence: Developed a robust GMP academy training program, providing essential knowledge to new employees and ensuring their effective contribution. 
  • Mentorship: Emphasizes the importance of comprehensive training and ongoing mentorship under the guidance of subject matter experts, fostering a culture of high standards in quality and safety.

INDUSTRIES

Life Sciences Division Team and GMP Subject Matter Experts

FAQs

Mabia Tavares is a master of excellence in the field of Good Manufacturing Practices (GMP) and contamination control. As a distinguished GxP Subject Matter Expert (SME) with a profound background in cGxP facilities services management, compliance, and training, her career is a testament to unwavering dedication and expertise. With extensive experience across the Biopharmaceutical and Semiconductor industries, Mabia has honed her skills in the crucial areas of GMP, Client and Contract Management, Life Science contamination control programs, and ensuring GMP/ISO compliance. Her ability to manage multidisciplinary project teams and her proficiency in languages, including Portuguese and Spanish, further exemplify her versatile skill set. 

Our technicians are trained in cGMP protocols, utilizing the latest in cleaning technology and practices to maintain your production environment’s integrity.

Yes, GDI’s services are tailored to meet the specific requirements of various industries, including pharmaceuticals, biotechnology, medical devices, and semiconductor manufacturing.

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Looking for a partner to help you meet GMP standards and ensure the integrity of your production environment?
Our dedicated team is ready to provide customized solutions that meet your specific needs. Reach out to GDI for more information on our GMP services today! 

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