PQM+ & COVID-19
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, and dietary supplements manufactured, distributed, and consumed worldwide. In Pakistan, Promoting the Quality of Medicines Plus (PQM+) Program is a Cooperative Agreement between the United States Agency for International Development (USAID) and USP. This cooperative relationship supports the Drug Regulatory Authority of Pakistan (DRAP) for regulatory reforms, quality assurance systems, and strengthening the quality control laboratories in Pakistan. Moreover, PQM+ also provides technical capacity building in close coordination with DRAP and provincial health authorities.
ACTIVITY OBJECTIVE:
PQM+ intends to conduct an awareness session and a Lead Auditor training course on ISO 15189 standards for selected hospitals and PQM+ staff. The training course will assist diagnostic labs to understand ISO 15189 standards and requirements, and will also aim to build the capacity of the PQM+ team to support and conduct gap assessment of diagnostic labs in selected hospitals. For this said activity, PQM+ requires hiring a third-party consultant to conduct the training.
1. To develop appropriate training materials on PQM+ format, which will be used to train other Auditors and Lead Auditors
2. To arrange an awareness session on ISO 15189 standards for selected hospitals/medical labs
3. To conduct Lead Audit Training on ISO 15189 Standards for the PQM+ team
4. The training should demonstrate how the standard is used in assessing the competence of medical laboratories
5. The training should include the topic related to biosafety and biosecurity
6. To ensure that all pre and post-training activities including training evaluations, training feedback is planned and executed professionally and in a timely manner
7. The training must also include a detailed demonstration on ISO 15189 accreditation process by PNAC or any equivalent body
8. To develop training reports on PQM+ reporting format.
MANDATORY DELIVERABLES:
- - Training reports
- - Training materials
- - Training certificates
- - Pre-Assessment Checklist
TRAINING COURSE TARGETED PARTICIPANTS:
We are estimating 15 participants from 05 from PQM+ Staff & 10 from Medical Labs.
Training Dates:
To be decided
Number of Days: 05
Number of Participants 15
MINIMUM REQUIREMENTS
1. At least 05 Years' experience in the relevant field.
2. Hands-on experience and work, with an understanding of ISO 15189 accreditation and training.
3. Demonstrated ability in developing policies, regulations, and guidelines related to ISO requirements.
4. Demonstrated ability to lead professionals and manage others through influence and collaboration.
5. Demonstrated ability to collect and interpret quantitative/qualitative information, with analytical problem-solving.
6. Proven leadership skills in consulting, with demonstrated experience in training and mentoring staff and others.
PERIOD OF PERFORMANCE
The scope of the work defined herein should be implemented before 30th June 2021. The assignment will be required 05 Working Days Level of Effort (LOE).
GEOGRAPHIC AREA
Selected firm/ individual will develop and work in consultation with the USP Pakistan team and deliver training at venue TBD.
REPORTING
Selected firm/ individual will report to the PQM+ Deputy Chief of Party.
EVALUATION CRITERIA
1. Past Experience - 30%
2. Qualification and Education - 30%
3. Financial Proposal- 40%
