Keena, who joined Oliver-Tolas in 2002, leads Oliver-Tolas' Global Quality Assurance and Regulatory Affairs team and is responsible for Quality Systems worldwide. She also leads process improvement initiatives, establishes and monitors customer-supplier relations, supports strategic planning and deployment and develops measurement systems to assess Oliver-Tolas' Quality Assurance Program. Lora's areas of expertise include international auditing; quality systems; and supplier, product, and process validation. She has extensive experience and proficiency in FDA cGMP, QSR, MDD, FDA and ISO 13485 registration and inspections, 510(k) pre-market notification, international medical device registrations, supplier management and related regulatory affairs.
“Lora's ongoing commitment to stay in tune with the changing world through obtaining this certification further demonstrates her commitment to Oliver-Tolas' quality policy “…to exceed customer expectations through the supply of safe and effective products…” Her expertise will help ensure that Oliver-Tolas' quality assurance program continues to meet the stringent standards of medical device and pharmaceutical manufacturers worldwide,” said Jerry Bennish, President & CEO, Oliver-Tolas Healthcare Packaging.