Lisa Reed has twenty-five plus years of experience ensuring GxP compliance within the biologics, and small molecule industries with advanced subject matter expertise within the Quality Assurance function. As a highly focused Global Quality professional, she is committed to working with development teams to create and maintain the highest possible quality standards.
Lisa brings considerable technical expertise in development, management and disposition for biologics and small molecules products as well as significant experience ensuring GCP compliance consistent with global regulations and industry expectations. She is the owner and President of L. Reed Global QA, Inc., a consultant company launched at the beginning of 2014. She is fully engaged in the biopharmaceutical life science segment, working with clients to assist in development of phase appropriate programs to meet industry cGxP requirements by staging products for disposition, regulatory audit support, vendor qualification and management of drug product programs. Concurrently L. Reed Global QA, Inc. works globally managing products within CDMO operations as QA Site Head of active manufacturing facilities. Work experience encompasses global early clinical phase development, clinical trial supplies in the clinical setting through commercial approval and serialization. Specific work experience can be viewed on the attached resume.
Ms. Reed’s professional dedication earned her an award from Eisai Inc., recognizing her contributions to the industry. Looking ahead, she intends to continue exploring new opportunities while remaining consistent in her consulting work. She has launched a pro bono mentoring program, emphasizing the importance of giving back to an industry that has provided her with employment and opportunities for engagement over the past three decades. With extensive experience in Singapore, Japan, N. America, and various European countries, Ms. Reed hopes to work globally again, seeking collaborations with companies that value seasoned quality assurance professionals.
Ms. Reed has been selected for inclusion in Marquis Who’s Who. As in all Marquis Who’s Who biographical volumes, individual profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process. The profile can be viewed here https://www.24-7pressrelease.com/press-release/524003/marquis-whos-who-honors-lisa-reed-ms-for-expertise-in-biotechnology-research.
Tom, has 30 + years of experience supporting aseptic processing operations for sterile products. He has key expertise with; Microbiological testing supporting raw material release, active processing, and drug substance/drug product release. Environmental monitoring qualification (EMPQ) and testing supporting controlled/classified cleanroom operation in compliance with cGMP standards. Microbiology support for utilities, pharmaceutical water systems, clean steam, compressed and process air. Ensures QC Microbiology operations are maintained in compliance with regulatory guidelines, industry trends, and customer requirements. Completion of quality system management system activities related to QC Microbiology: Deviations, CAPA, change control, out of specification investigations. Process simulation (Media Fill), Gowning qualification programs, autoclave validation. Contamination Control: Disinfectant efficacy, cross contamination, personnel monitoring, clean room behavior, and traffic flow. Complete support for Annex 1 requirements and able to perform gap analysis assessments. Tom’s knowledge and expertise enhances the services of L. Reed Global QA, creating QC microbiology capabilities as a new service opportunity.
Specific work experience can be viewed on the attached resume.
Pam brings a variety of seasoned experience to the L. Reed Global QA organization providing GxP regulatory expertise to the life science industry. She is a chemical engineer/computer scientist with 30+ years of experience in quality assurance and information technology in regulated industries and government agencies. She provides consulting services to life science organizations by leveraging transformational systems technologies to improve GxP processes. From 1996 to 2011, Pam was a principal at The Johns Hopkins University Applied Physics Laboratory, where she oversaw 200 staff members in diverse projects. For the last 14 years, she has been supporting life science companies in quality assurance, risk management, systems validation, and process development through her consulting operations.
Pam has significant expertise in creating Document Control Systems in a variety of software routinely used by the life science industry, including, part 11 compliant validation of Veeva Vault and document repository development in SharePoint, creating meta data traceable document repository systems. She also provides GMP support with batch record review and document management ensuring 100% retrievability of data. Additionally, she provides support for QA GCP clinical operations labeling & packaging. She is a valued member of the team and easily assimilates to clients’ needs and projects that benefit from her unique multi-level industry experience.
