Trainer Profile

Brenda Lydia Babirye
Contact Details
Teaching Experience (Years)
8+
Professional Experience (Years)
15+
Profile Summary
Highly competent chemist with a proven track record in Analytical method development, Quality management systems, Computer system validation, Good Laboratory Practices and Equipment maintenance/calibration of major equipment in a Laboratory. Highly experienced and certified ISO/IEC 17025 Trainer, Senior Lead Implementer and Senior Lead Assessor with over 15 years of expertise in laboratory quality management systems across diverse sectors including pharmaceuticals and calibration labs. Proven track record in guiding laboratories to successful accreditation through tailored implementation strategies, internal audits, documentation development, and staff training. Certified Senior Lead Auditor with over 10 years of experience in auditing, implementing, and maintaining ISO 9001 Quality Management Systems across diverse industries. Skilled in undertaking audits, identifying process inefficiencies, and guiding organizations toward continual improvement. A trained, meticulous and experienced GMP Inspector with over 10 years of hands-on expertise in pharmaceutical manufacturing compliance, in accordance with regulatory standards including WHO, PIC/S and national regulatory authorities. Established expertise in identifying non-conformities, advising on corrective actions, and supporting facilities in achieving or maintaining regulatory approval. Specialized in auditing and interpreting the WHO GPQCL and ISO/IEC 17025:2017 requirements and aligning lab practices with international standards. Proficient in conducting gap analyses, risk-based thinking integration, and continual improvement activities. Have headed a Laboratory Quality Management unit at the National Drug Quality Control Laboratory where I established, implemented and maintained a robust quality management system and led the laboratory through successful WHO-prequalification and ISO/IEC 17025 accreditations. Skilled in delivering interactive and focused training sessions for lab personnel, quality managers, and technical staff. Provided hands-on mentorship to junior quality staff and facilitated training sessions on ISO 17025:2017 and WHO GPQCL requirements, resulting in improved audit readiness and documentation practices. Trained and built capacity of laboratory analysts from various local pharmaceutical manufacturing industries in Uganda, on method validation, data integrity and Computer Systems Validation. Extensive knowledge and understanding of computer systems validation, a critical component in implementation and management of Laboratory software. Strong
Trainer specialities and experience
Here is a detailed description of the courses that the trainer is specialized in and their related experience.