PRESOL | U | Current Good Manufacturing Practices Certification Program for the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD).

FBO DAILY ISSUE OF JULY 12, 2012 FBO #3883
SOLICITATION NOTICE

U -- Current Good Manufacturing Practices Certification Program for the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD).

Notice Date: 7/10/2012
Notice Type: Combined Synopsis/Solicitation
NAICS: 611430 — Professional and Management Development Training
Contracting Office: ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
ZIP Code: 01760-5011
Solicitation Number: W911QY-12-T-0017
Response Due: 7/17/2012
Archive Date: 9/15/2012
Point of Contact: Richard Totten, 301-619-2446
E-Mail Address: ACC-APG - Natick (SPS)
(richard.totten1@us.army.mil)
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. A. Synopsis/Solicitation: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. The solicitation number is W911QY-12-T-0017 and is issued as a request for quotations, unless otherwise indicated herein. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-50. The associated North American Industrial Classification System (NAICS) code for this procurement is 611430 with a small business size standard of $7,000,000.00. B. Purpose: The purpose of this procurement is to award of a Firm Fixed Price Purchase Order for instructor led classes to be held at Aberdeen Proving Ground, Aberdeen, MD, to provide an in-depth, on-sight academic training and certification program on current Good Manufacturing Practices (cGMPs). C. Description of Work: Performance Work Statement Current Good Manufacturing Practices Certification Program TITLE: Current Good Manufacturing Practices Certification Program for the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) in support of the Medical Acquisition (MED-ACQ) Directorate, Joint Program Managers, and other Stakeholders. C.1. General C.1.1 Scope. JPEO-CBD MED-ACQ Directorate requires an in-depth, on-sight academic training and certification program on current Good Manufacturing Practices (cGMPs). This certification program shall be comprised of four separate, 2-3 day classes, with an administered certification exam upon completion of the fourth class. Classes shall include the following four topics: 1. The fundamentals of cGMPs 2. The process of validation for drugs and biological products, 3. cGMP Quality Principles for pharmaceuticals, biopharmaceuticals, biological products and medical devices, 4. An overview of the U.S. Food and Drug Administration (FDA) regulatory compliance for drugs and biotechnology products. C.1.2 Background. JPEO-CBD MED-ACQ Directorate has the mission to provide independent assessments and portfolio management to the Joint Program Executive Officer for Chemical and Biological Defense. MED-ACQ provides one medical voice for the JPEO-CBD position, as well as the acquisition, medical and pharmaceutical expertise necessary for insight into the medical portfolio. JPEO-CBD MED-ACQ Directorate employs acquisition analysts, systems engineers, regulatory specialists, pharmaceutical scientists, and healthcare informaticians. In order to provide a sound assessment and analysis of medical acquisition programs, it is imperative that MED-ACQ staff, as well the Joint Program Managers and other Stakeholders have a clear understanding of the FDA's regulations with regard to the manufacturing practices and quality principles involved in the development of drugs, biologics, pharmaceuticals and medical devices. C.1.3 Period of Performance. The first course shall begin on August 13, 2012, and the contractor shall meet the schedule requirements for course offerings as specified below: -August 13 - 14, 2012 -September 10 - 11, 2012 -October 1 - 3, 2012 -November 12 - 14, 2012 C.1.4 Place of Performance. To minimize travel cost for the government and optimize the training of participants, as well as allow individuals to achieve certification, training and certification exams will be conducted locally, on Aberdeen Proving Grounds - Edgewood Area, Aberdeen, MD, at an onsite classroom location. C.1.5 Dates of Training and Certification To meet the time restraints of Government staff, each course shall not exceed the duration of 3 business days, and coursework shall be provided once a month over a period of four months until completion of the certification program. The first course shall begin on August 13, 2012, and the contractor shall meet the schedule requirements specified in C.1.3. The cGMP certification exam shall be administered during the last day of the final course offering. C.1.6 Program Management and Key Personnel Contractor must provide an onsite classroom instructor(s) with at least 20 years of valuable experience in the areas of cGMP compliance, quality systems, regulatory compliance and validation functions and responsibilities. It is required that the instructor(s) have past experience in the Biopharmaceutical industry and/or FDA. Classroom instructor(s) must also have experience in performing internal/external cGMP audits and start-up of manufacturing facilities. The instructor(s) will be physically present during normal duty hours and conduct all academic training. The instructor shall be the contractor's primary point of contact during training. C.1.7 Identification of Contractor Personnel. The contractor shall ensure the classroom instructor identify themselves as a contractor employee with the name of their company. C.2 Requirements The contractor shall perform the following: 1.Provide a classroom instructor IAW criteria outlined in this PWS, to provide onsite professional training. 2.Provide all training materials to include textbooks, course notes, instruction manuals, and any other materials required for successful training and certification on the Fundamentals of cGMP, Process Validation for Drugs and Biologics, FDA Regulatory Compliance and Quality Practices. 3.Provide cGMP Certification Exam to all class participants that have met the exam requirements. 4.Provide cGMP Certification documentation to all participants that have successful passed the exam. 5.Coordinate the with the Technical POC listed in C.5 for the location of each class in accordance with the specified date and time within the local Aberdeen Proving Grounds - Edgewood Area. Contact should be made 5 days prior to class start date. C.3 Deliverables and Delivery Schedule Contractor shall provide four 2-3 days classes for up to 25 personnel to obtain certification on current Good Manufacturing Practices (cGMP). Class curriculum must be comprised of the following classes, with a cumulative certification exam upon completion of the final class: (1)current Good Manufacturing Practices (cGMPs), (2)Process of Validation for drugs and biologics, (3)Quality Principles for drugs, biologics, biopharmaceuticals and medical devices and (4)Overview of FDA Regulations for Drugs, Biologics and Vaccines. C.4 Government Furnished Facilities, Equipment, Materials and Services The Government will provide the necessary facilities to house the on-site training, as well as equipment (projectors) and technical support to accommodate these services. C.5 Contracting Office Representative(s) (COR) A COR will not be appointed to this contract, however a technical POC shall be appointed upon contract award, to communicate with the contractor on classrooms and set up, as well as access. C.6 Non-Personal Service Statement Contractor employees performing services under this contract will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in this PWS. Contractor employees will perform their duties independent of, and without the supervision of, any Government official. The tasks, duties, and responsibilities set forth under this PWS may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). D. Instructions, Conditions, and Notices to Offerors Quotations shall be submitted electronically in accordance with FAR 52.212-1, Instructions to Offerors, Commercial Items, in Microsoft format (Excel, Word) to the Point of Contact (POC) listed below, by 4:00 pm ET, 17 July 12. The POC shall issue a receipt acknowledgement upon receipt to confirm submission. The quotation shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of stated claims. The quotation should not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the Offeror intends to meet these requirements. The Offeror shall assume that the Government has no prior knowledge of the Offeror's facilities and/or experience and the Government will base its evaluation on the information presented in the Offeror's quotation. All questions pertaining to this request shall be submitted by email to the POC listed below, no later than 4:00 pm, 12 July 2012. First page of the quotation must provide the company name, location, DUNS, CAGE, POC, and TIN. The quotation acceptance period shall be a minimum of 30 days. E. Evaluation and Selection The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to this solicitation is determined best value to the Government, price and other factors considered. The following factors shall be used to evaluate offers: 1) Technical Capability 2) Past Performance 3) Price Technical and past performance, when combined, are approximately equal to price. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the offer. The Government reserves the right to make an award without discussions. The Government reserves the right to award on all or none basis. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. As part of its proposal, the offeror will provide the estimated total cost (if any) incurred to comply with the Contractor Manpower Reporting Application (CMRA) requirement. Offerors will determine to price or not-separately-price the CMRA requirement. Priced CMRA requirements shall be denoted as a separate CLIN, under which the contractor shall bill for all costs associated with the CMRA requirement. The CMRA website, https://cmra.army.mil/, can be accessed to provide responses to questions related to this requirement. F. Provisions and Clauses: The selected Offeror must comply with the following commercial item terms and conditions, which are incorporated herein by reference: FAR 52.204-7 Central Contractor Registration FAR 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards FAR 52.212-3 Alt I, Offeror Representations and Certifications - Commercial Items - the offeror must submit a completed copy of the listed representations and certifications with their offer. DFARS 252.212-7000, Offer Representations and Certifications - the offeror must submit a completed copy of the listed representations and certifications with their offer FAR 52.212-4, Contract Terms and Conditions - Commercial Items FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items - the following clauses cited hereby apply: 52.222-3 Convict Labor 52.222-19 Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-35 Equal Opportunity for special Disabled Veterans and Veterans of the Era and Other eligible Veterans 52.222-36, Affirmative Action for Workers with Disabilities 52.222-37, Employment Reports on Veterans 52.222-40 Notification of Employee Rights Under the National Labor Relations Act 52.223-18, Contractor Policy to Ban Text Messaging While Driving 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration 52.222-41 Service Contract Act of 1965 52.222-42 Statement of Equivalent Rates for Federal Hires FAR DFARS 252.212-7001, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items, applies to this acquisition. The following clauses cited within 252.212-7001 apply: 252.203-7000 Requirements Relating to Compensation of Former DoD Officials 252.225-7001 Buy American Act and Balance of Payments Program 252.232-7003, Electronic Submission of Payment Requests 252.203-7002, Requirement to Inform Employees of Whistleblower Rights 252.204-7004, Alternate A, Central Contractor Registration 252.247-7003 Transportation By Sea. The full text of the referenced FAR clauses may be accessed electronically at http://www.farsite.hil.af.mil. G. Contracting Office Address: ACC-APG - Natick Contracting Division, Ft Detrick 1564 Freedman Dr., Ft Detrick, MD H. Place of Performance: Aberdeen Proving Grounds, Aberdeen MD I. Point of Contact(s): Richard Totten, at 301-619-2446, or Richard.totten1@us.army.mil
Web Link: FBO.gov Permalink
(https://www.fbo.gov/notices/95f9d6b6fdae75e0967778bef204163f)
Place of Performance: Address: Joint Program Executive Office for Chemical and Biologica Defense 5183 Blackhawk Rd, Bldg. E5101 APG MD; Zip Code: 21010
Record: SN02798874-W 20120712/120711000846-95f9d6b6fdae75e0967778bef204163f (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

U -- Current Good Manufacturing Practices Certification Program for the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD).