ABOUT US:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) Technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.

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 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 OBECTIVE:

PQM+ team intends to hire consultant to conduct an awareness training course (Virtual/In-person) on ISO 13485 standards for PPE manufacturers. As one of the activities under the current PQM+ COVID-19 project, PQM+ intends to build the capacity of, and enable PPE manufacturing firms to prepare for ISO 13485 certification audits. For the said activity, PQM+ requires to hire a third-party consultant to conduct the training.

1. To develop appropriate training materials on ISO 13485 Standards for PPE manufacturers
2. To conduct training(s) on ISO 13485 Standards for PPE manufacturers.
3. The training must include regulatory requirement for ISO 13485.
4. The training must also include detailed demonstration on ISO 13485 accreditation process by PNAC or any equivalent body.
5. To ensure that all pre and post-training activities including training evaluations, training feedback are planned and executed professionally and timely
6. To develop training reports on PQM+ reporting format

TRAINING COURSE TARGETED PARTICIPANTS:

We are estimating 25 participants from 05 from PQM+ Staff & 20 from PPE manufacturers.

MANDATORY DELIVERABLES: 

• Training reports
• Training materials
• Pre and post-training evaluations
• Training certificates for participants
• Participant training feedback

MINIMUM REQUIREMENTS: 

1. At least 05 Years’ experience of conducting trainings on ISO 13485 Standard.
2. Hands-on experience and work, with an understanding of ISO 13485 Certification.
3. Demonstrated ability in developing policies, procedures, and all required documents related to ISO requirements.
4. 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 5 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.

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% 

IMPORTANT NOTE:

The Consultant (Firm/Individual) is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.

Please send CV/Profile, 3-References, and Daily Rate by downloading following ANNEX – D (Template):

https://drive.google.com/file/d/1SNQftPHB25vpRZTcznnsDrFRB8d2r7d1/view?usp=sharing

The Quoted Per Day Rate should be inclusive of all applicable taxes, traveling and any other associated costs.

Kindly send all Technical and Financial Proposal to ATTN:  USP Pakistan Procurement at [email protected] before the closing date April,14^th 2021. When submitting your application, write "Awareness Training Course for PPE Manufacturers- Pakistan" in the email Subject Line.