Biologics and Biosimilars

Biography

With over 27 years of experience in the GMP Regulated Industries environment in the areas of Regulatory Compliance, Quality Systems, Regulatory Affairs, and Manufacturing. Mayra hold a Master of Science in, Thermodynamics and Materials Sciences Engineering from the University of Cincinnati, OH, and 2 Bachelor in Science, (1) in Analytical Chemistry, and (2nd) in Chemical Engineering from the University of P. Mayra had over 27 years of experience and depth knowledge of FDA, EMEA, ANVISA, COFEPRIS, ANMAT, CFDA KFDA, TGA, PMDA, INVIMA, SFDA ISO9001, ISO13485, Canadian Medical, Device Regulations, ICH Guidance, and others environment. She had experience managing including; facilities/utilities, equipment, De- Commissioning, Commissioning, Plant Startup, Validation Projects within pharmaceutical, Biotech, Medical Devices companies in the United States, Europe, Asia, Latin America, and Puerto Rico. Also Mayra’s experienced in the areas of Regulatory Compliance, Quality Systems, Regulatory Affairs, Design Controls, QSR, Quality Control, Quality Assurance, GAP analysis, extensive experience in FDA, – 483, Warning Letter and Consent Decree responses and remediation work plan strategy, Implementation of Quality Programs, SOP Development. Record of accomplishment for consistently meeting goals and delivering a high level sustained performance, proven the ability to build strong customer/client relationship including conducting vendor audits and contract manufacturing oversight. In addition, Mrs. Guzman-Kaslow prior experience includes auditing of Quality Systems, Design Controls, QSR, Quality Control, Quality Assurance, including Regulatory Compliance Audits, Deviation, OOS, CAPA, Complaints Investigation, Field Actions, and Validation, CSV, for Pharmaceuticals, APIs, Biotech, Biosimilars, CMOs, Medical devices including Device History, Design History, GAP analysis and remediation; Control Systems; Pharmaceutical Equipment; Electronic Records & Electronic Signatures (21 CFR Part 11); and computer/software, utilities, and manufacturing processes. Most recent, Mayra is the President & CEO of GK Regulatory Compliance in US and the General Manager of GK Pharmaceuticals CMO PR. She’s well known in the Biotechnology – Biosimilars industries in India and Europe. She was trained and certified by one of the gurus and innovators in Biosimilar.

Research Interest

Biosimilars, Regulatory Compliance, Quality Systems, Regulatory Affairs, Design Controls, QSR, Quality Control, Quality Assurance, GAP analysis, extensive experience in FDA, – 483