Quality & Compliance Consulting for GCPs & GLPs
Whatever changes you’re hoping to make or goals you’re trying to achieve, we will provide you with sound advice and professional guidance every step of the way. Take a look at our site and see all that we can do for you today.
Services
Your Strategic Partner
We have the knowledge and experience to meet and exceed your expectations and offer a variety of Quality Assurance Services customized to fit your specific needs. Learn more about the improvements we can help you achieve, and contact me today.
Quality Management System
Expert Guidance
We can author, review, evaluate and implement documentation and quality management systems (GxP procedures and related forms, policies, quality manuals, business continuity plans, and risk mitigation plans). Our expertise includes development of continuous process improvement plans and CAPA implementations.
Auditing
Assurance of Compliance
Audit services cover a wide range to ensure compliance, data integrity, appropriateness and adequacy of systems and processes:
GCP Vendor Qualification
GLP Mock FDA Inspections
GDocP Internal Audits
GAP Analysis Clinical Site Audits
Data/Reports Investigator Brochures
Audit venues may be internal, clinical sites, laboratories, preclinical facilities, CROs, and other vendors. Experienced in performing remote/desktop audits. This virtual approach to auditing may be used for most types of audits.
Training
Focused & Current
Training provided for all aspects of GCP and GLP Compliance:
CFR ICH EU
Additional specialty training programs for:
Managing Regulatory Authority Audits
Conducting GCP/GLP Audits
CAPA Management
Vendor Qualifications.
Kathleen (Magliere) Zajd
B.S., CQA, RQA-GCP, CQM-OE
Quality Assurance professional with 25+ years of experience performing multi-cultural/ international audit programs, creating and maintaining Quality Management Systems to achieve organizational excellence and leadership experience across the GxPs. Expertise in establishing and maintaining Quality Management Systems that comply with GCPs, GLPs, GMPs and ISO standards. Adept at managing risk to protect patient safety, data integrity, and privacy. Broad therapeutic experience in pharmaceutical, medical device, academic and contract research arenas. Audit experience and regulatory authority interactions include; internal processes, clinical sites, preclinical facilities, laboratories, inspection readiness, ISO 9001 & 14155, data analysis and integrity, TMF, CAPAs, study reports, software validation, vendor qualification. Successful record of creating and implementing quality strategies for continuous improvement that brings value to stakeholders; as well as compliance programs that support the business and strategic direction of the company. Sincere interest in mentoring and coaching staff and organizations on an organizational, sociological and technical level to improve compliance, resilience, and success.