Compliance Architects® is pleased to announce that Georgina (Dina) Maines has joined our team as a Managing Consultant.
Dina has more than 30 years of experience working in the pharmaceutical and life sciences industry space, and most recently spent a year as the acting Head of Quality for a mid-size pharmaceutical client. During her long tenure in the industry, Dina has worked as a microbiologist; within technical operations (manufacturing and packaging operations) for both large and mid-size pharmaceutical firms; and in executive quality and compliance roles. Dina has created quality systems and control programs; successfully remediated quality systems for companies under regulatory distress; and conducted domestic and international audits for raw material and service providers.
Dina’s technical expertise includes deep understanding of the technologies used in solid oral dosage forms, liquids, transdermals, sterile products, thin-film, and drug/device combination products.
Dina’s quality system experience includes implementation leadership for quality management systems including training and exception management (change management, CAPA, and document controls). She has written policies, procedures, work instructions, and batch records, and has developed and trained staff for production operations, QA support functions, batch record review, and inspection readiness.
Dina’s compliance background includes a deep understanding of and respect for the laws that govern FDA-regulated industry. Dina excels at the creation and maintenance of systems to ensure effective pharmaceutical compliance programs and benefits from a deep understanding of laboratory practices, production operations, quality assurance and control, and compliance programs.
Dina’s regulatory knowledge includes a comprehensive knowledge of requirements and expectations for NDA, ANDA, 510(k) and associated regulatory filings. Dina has extensive experience with CMC reviews prior to submission; pre-approval inspection preparation and readiness; and has a proven track record of facilitating successful pre-approval inspection outcomes.
In her role as a Managing Consultant, Dina will serve as a lead subject matter expert and delivery lead for regulatory, quality management and compliance matters with pharmaceutical industry clients. We are thrilled that Dina has chosen to join Compliance Architects® as she continues her successful career in FDA-regulated industry.
Please join us in congratulating Dina and welcoming her to our team!