NSF Health Sciences Pharmaceutical products and services

 

NSF Health Sciences partners with life science companies of every size and kind to provide highly tailored consulting, auditing and training services.

In line with its “The Right People. The Right Solution. The First Time.™” approach, NSF Health Sciences helps clients improve quality, compliance and safety at every stage of the product lifecycle.

Services

From early development to commercial manufacture and distribution, NSF Health Sciences can help clients to:

• Ensure regulatory compliance
• Implement effective quality management systems
• Maximize human capital
• Assure highest product quality and safety
• Improve competitive edge

The company offers three main service lines:

Consultancy

NSF’s consultants are subject matter experts capable of providing professional and effective advice across the product lifecycle, from development through registration and to technical transfer, manufacture and eventual discontinuation.

Consultants’ fields of expertise include supply chain management, regulatory compliance, fraud, safety, risk assessment, organizational culture, customized training and crisis management.

They are also available to evaluate product formulations, compliance and composition; provide technical reviews of manufacturing processes, quality systems and standards; and help develop protocols and procedures.

Go to the NSF Health Sciences Pharma Biotech Consultancy Page to read more about these and other services, including:

• FDA / PAI Readiness Training
• Interim Leadership and Support Roles
• Subject Matter Expertise
• Due Diligence for Acquisitions
• Litigation Support and Expert Testimony
• Compliance and Integrity Programs

Auditing

NSF Pharma Biotech performs audits against all major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and more. Rather than simply telling clients where they fail to comply, NSF provides essential, pragmatic advice on how to achieve compliance in a cost-effective way. NSF consultants also work with clients to ensure that remedial action plans are comprehensive, effectively implemented and, where appropriate, fully documented.

NSF’s auditing teams expertise covers:

• Quality System Audits
• Data Integrity Audits
• Mock Inspections
• Compliance / Third-Party Audits (FDA, EMA, HC, TGA)
• GLP, GCP, CLIA and BIMO Audits
• OTC cGMP Audits
• Excipient cGMP Audits

To find out more about the NSF Pharma audits go to the Audit Page on the NSF website.

Training

NSF is internationally renowned for high quality training and education, with a range of programs and services to meet almost all client needs. These range from public courses for career progression, e.g. for Qualified Person (QP) or senior quality professional, through training groups of staff in-house in changes in procedures and regulations, all the way to effecting culture change within an entire organization.

NSF courses receive extremely good feedback, not least because its tutors are all experts in their field with typically at least 30 years industry or regulatory agency experience.

Public courses

NSF’s Pharma Biotech public courses cover subjects relating to pharmaceutical manufacturing, auditing and quality management.
The core programs are:

• The modular Qualified Person program
• Effective Pharmaceutical Audits and Self Inspections
• Human Error Reduction

Other topics include:

• Deviation reporting and CAPA
• Pharmaceutical Good Manufacturing Practice (GMP)
• Pharmaceutical legislation updates
• Good Distribution Practice (GDP)
• GMPs for clinical trials manufacturing
• Sterile products manufacture
• Preparing for regulatory inspections

Courses are hosted at a wide range of locations in the USA and Europe, including the UK, the Netherlands, Germany, France and Belgium. Click Here for the course calendar.

Modular Qualified Person Program

In the UK, NSF (formerly NSF DBA -David Begg Associates) has partnered with the University of Strathclyde to develop the modular Qualified Person program, considered best in class all across Europe.

The QP Program consists of 12 modules that are offered over 21 months and that meet the requirements for theoretical training as detailed in EC Directives 2001/20/EC, 2001/82/EC and 2001/83/EC and in the latest Qualified Person Study Guide.

Face-to-face tuition prepares candidates to perform QP roles in today’s pharma industry, focusing on the knowledge and practical decision-making exercises to build the necessary skills and confidence.

NSF provides unparalleled support, including training plan development, gap analysis, a supportive tutor system, QP skills training, support with application and revision interview, and a strong alumni organization. The chance of passing a QP assessment is higher with NSF than with any other provider.

A full overview and course calendar can be found on the NSF website. Full Course and Calendar

In house training

NSF Pharma Biotech can bring expert trainers to the client’s door with specifically designed in-house training courses. These courses can vary in duration from half day up to five days. The optimum attendance is 12 to 25 delegates.

Drawing from an extensive library of cGMP, regulatory and technical topics NSF offers standalone courses as well. In fact all NSF courses can be customized and delivered at a client site.

Read more on the page. Training at your site

Resources

Click on NSF Health Sciences for other information.
Click on NSF Health Sciences to contact the company directly.

Supplier Information
Supplier: NSF Health Sciences
Address: The Georgian House, 22/24 West End, Kirkbymoorside, York, YO62 6AF, UK
Tel: +44 (0) 1751 432999
Fax: +44 (0) 1751 432450
Website: http://www.nsf.org/services/by-company/health-sciences/

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