Jose possesses a distinguished career spanning over 30 years as a retired FDA investigator and compliance officer. Throughout his tenure with the FDA, he conducted a diverse array of investigations, compliance assessments, and laboratory inspections on a global scale. While at the FDA, he achieved Level 5 US secret clearance and garnered certifications as a Level III Drug Investigator and Criminal Investigator.

His vast experience encompasses various facets, including Six system cGMP pharmaceutical auditing, pre-approval and routine cGMP pharmaceutical auditing, OOS investigations, and inspections of medical devices and biological products.

During his leisure hours, Jose derives fulfillment from house remodeling projects and cherishing quality time with his family.

Anita is a seasoned industry consultant with nearly two decades of experience. She holds a biomedical engineering degree from Virginia Tech and commenced her career at Wyeth Pharmaceuticals and then Pfizer, gaining expertise in solid oral dosage, topical, and liquid manufacturing operations. Her extensive background encompasses process and CSV validation, equipment qualification, project management, and overall process enhancements.

While working at Pfizer, she also pursued and earned her MBA at the University of Richmond. Subsequently, she served as a client-facing Account Manager for a software development company and later assumed the role of an industry GMP Auditor at Novartis. For over a decade, she conducted a wide range of GMP audits, specializing in CSV, SaaS, SaaMD, Medical Device/Combination product, and drug product audits. In her final two years at Novartis, she oversaw the auditor training and certification program. Anita holds certifications as a CQIA and GTP auditor, possesses Lean Six Sigma certification, and has experience in project management.

In her leisure time, Anita finds joy in running ultra distances with her husband and cherishing moments with her three children.

Nancy is a seasoned retired FDA investigator and compliance officer, dedicating over 25 years of her career to service in this field. Her extensive experience includes a decade as an investigator and more than 14 years as a compliance officer, where she assessed the legal adequacy of information supplied by fellow investigators.

Throughout her tenure, Nancy conducted inspections across all regulated commodities, with a specialization in pharmaceuticals and food, including aseptically packaged foods. Furthermore, her background features work in industry microbiology and chemistry laboratories.

During her leisure moments, Nancy finds pleasure in activities such as hiking, camping, and photography.

Jannette Torres is a seasoned Quality and Compliance consultant with over 25 years of extensive experience in the pharmaceutical industry. She earned her Bachelor of Science degree in Chemistry from Universidad de Puerto Rico, Cayey Campus, and further advanced her education by completing a master's degree in project management at Universidad de Barcelona.

Since her entry into the pharmaceutical industry in 1995, Jannette has held a range of leadership positions across various critical areas, including Quality Control, Quality Assurance, Manufacturing, Regulatory Compliance, Data Integrity, Product Development, Validations, CAPAs, Material Management, Supply Chain, and Quality Systems.

In 2011, Jannette transitioned into consultancy, where she has actively contributed to numerous remediation projects. Her roles have encompassed being a Lead Investigator, a meticulous data integrity auditor, and a proficient GMP Auditor for Contract Manufacturing Facilities. She has consistently garnered recognition for her profound expertise, exceptional skills, and adept client communication.

Furthermore, Jannette leverages her expertise to design and deliver comprehensive training programs in Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Deviation Management Systems.

Beyond her professional endeavors, Jannette is a devoted pet lover and passionately volunteers her spare time to support Animal Rescue Organizations.

Maria Jesus is currently serving as an industry consultant with over three decades of expertise in cGMP and EU/FDA Regulatory Compliance. She holds a degree in Pharmacy from the Universitat de Barcelona and a Ph.D. In her career, she has held the position of Quality Director for APIS and final dosage in various companies across Europe, the United States, and South America.

Maria has led as a global auditor in over 50 quality audits, encompassing various types of suppliers (manufacturers), contract labs, services, and internal audits. Among her capabilities, she excels as a Quality advisor for startup initiatives related to gene therapy medicinal products and tissue engineered products. She also possesses extensive experience as a Trainer, providing specialized training programs on industrial quality topics, quality system design and implementation, quality audits from a GMP perspective, and the oversight of quality systems in compliance with GxP standards.

In her free time, she takes pleasure in indulging in activities like diving, running, leisurely beach strolls, and spending quality moments with her sister, nieces, and mother.

Carlos possesses three decades of varied experience in the Pharmaceutical, Medical Device, and Biotech Industry, serving as a Senior Quality Assurance and Regulatory Compliance professional. His expertise spans multiple areas, including Manufacturing Quality Assurance, Aseptic Coaching, Investigations, Validation Support, Regulatory Compliance, Remediation, Documentation, and involvement with cross-functional departments such as Metrology, Maintenance, Validation, Engineering, Manufacturing, Material Management, R&D, Quality Assurance, Training, and Document Control.

Retired in December 2020, Felix brings 30 years of dedicated service with the US Food and Drug Administration (FDA). His extensive background includes roles as a Drug Chemist Specialist and Scientist Investigator.

In his capacity as a Drug Chemist Specialist, he conducted thorough analyses of dosage forms adhering to USP compendial methods. He also played a key role in reviewing method validation/verification procedures, operated and maintained laboratory equipment, conducted inspections of pharmaceutical drug QC laboratories, and provided valuable training to junior chemists and FDA investigators in laboratory QC operations and cGMP.

Transitioning into the role of a Scientist Investigator, he conducted FDA six systems cGMP pharmaceutical inspections for producers of pharmaceutical products. This encompassed Active Pharmaceutical Ingredients (APIs), OSD (tablet and capsules), semisolid (cream and ointments), and sterile (SVP/LVP & Lyophilized). His responsibilities extended to performing numerous preapproval and post-approval inspections for producers of APIs, biotech products, sterile and non-sterile formulators, and contract laboratories, both within the USA and internationally. His wealth of experience ensures a comprehensive understanding of pharmaceutical quality control and regulatory compliance.

During his free time, he enjoys exploring new places and seeking out novel experiences.