Quality System Regulation Training: 21 CFR 820 and ISO 13485

Closed Solicitation Posted

Solicitation number
FDA-21-RFQ-1242552
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
611430 Professional and Management Development Training
PSC
U004 Education/Training- Scientific/Management
Place of performance
Silver Spring, Maryland 20993, United States

Notice details come from SAM.gov. Updated .

Notice text

2 versions

Update #2 · Latest ·

Amendment # 00001 -- FDA-21-RFQ-1242552. -- Title:  Quality System Regulation Training: 21 CFR 820 and ISO 13485. 

This amendment extends the submission date to Monday, August 30, 2021 by 4:30 PM ET.  There  are no additional changes to FDA-21-RFQ-1242552.  Please send your quote to Sharon.Masciana@fda.hhs.gov by the revised submission date with the signed Amendment 01. (new attachments)

This is a combined synopsis/solicitation for commercial services prepared in accordance with the Federal Acquisition Regulation (FAR) format Subpart 12.6, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06/2021-07-12.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is:  FDA-21-RFQ-1242552  and is being issued as a Request for Quote (RFQ). The solicitation is being issued in conjunction with FAR PART 13.106. The associated North American Industry Classification System (NAICS) Code for this solicitation is 611430.  This requirement is Full and Open Competition.  Prospective Offerors are responsible for downloading the solicitation and any amendments.  The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing lowest price technically acceptable and discussions are not necessary.

Contract Type-Commercial Services – Firm Fixed Price’

Purpose:  The U. S. Food and Drug Administration (FDA), Center for Biologics Evaluation & Research (CBER)

 has a need to procure a Quality System Regulation Training:  21 CFR 820 and ISO 13485.

Contact: Sharon.Masciana@fda.hhs.gov 

Update #1 ·

This is a combined synopsis/solicitation for commercial services prepared in accordance with the Federal Acquisition Regulation (FAR) format Subpart 12.6, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06/2021-07-12.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is:  FDA-21-RFQ-1242552  and is being issued as a Request for Quote (RFQ). The solicitation is being issued in conjunction with FAR PART 13.106. The associated North American Industry Classification System (NAICS) Code for this solicitation is 611430.  This requirement is Full and Open Competition.  Prospective Offerors are responsible for downloading the solicitation and any amendments.  The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing lowest price technically acceptable and discussions are not necessary.

Contract Type-Commercial Services – Firm Fixed Price’

Purpose:  The U. S. Food and Drug Administration (FDA), Center for Biologics Evaluation & Research (CBER)

 has a need to procure a Quality System Regulation Training:  21 CFR 820 and ISO 13485.

Contact: Sharon.Masciana@fda.hhs.gov 

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