Subject Matter Expertise
- Our Training Style
- Our Consulting Skills
- Our Audit Support
We believe that our team of experts are the best available. Not only do they have years of experience in the pharmaceutical industry, but they are committed to educating and helping those inside the industry to improve and raise the standards. We understand that you attend courses or commission consulting work to learn about latest regulations or to get advice, questions answered and your problems solved. Our customer feedback indicates that we help both individuals and organizations to develop and grow.
Our team is hand-picked and has extensive industrial and, in some cases, regulatory agency experience. We are fully up to date with the very latest international regulatory and GMP compliance requirements and we have the experience to help you to implement efficient, cost-effective solutions to your technical and regulatory challenges.
We pride ourselves in the depth of knowledge and experience of our teams; they all have hands-on experience that translates into the support they provide to you. We look for simplicity in compliance and help you to reduce complexity and bureaucracy.
Our Training Style
At NSF, we believe that training should be informative, involving, participative, relevant and above all fun. All of our training courses, whether at your site or ours, maximize participation and involvement by providing a balanced mix of lectures, tutorials and participative team-based learning.
As for the fun element, no one says that GMP training has to be dull. We strive to make all courses enjoyable; you will spend as much time smiling and laughing as you do writing.
Our Consulting Skills
Staying at the leading edge of pharmaceutical training means that we keep abreast of every major industry issue. You can put that knowledge to good use by taking our advice on a broad range of regulatory and technical matters, including:
- Quality management systems: deviation and CAPA, complaints, OOS, documentation systems
- All dosage forms: the complexities of sterile manufacturing, biopharmaceuticals, vaccines
- Assistance with responses to regulatory inspection reports, warning letters, etc.
- Support in preparing for regulatory visits
- Advice on facility design, validation and operation
- Review of validation plans and completed studies
- Regulatory compliance for computers and automated control systems
- Specialist microbiological advice
- Specialist advice on water systems and autoclaving
Our Audit Support
We can assist you in your search for the ideal contractor by performing audits on your behalf to any GMP standard for:
- Production, packing, testing, storage and distribution, engineering
- Computer software, water systems, autoclaves
- Raw material suppliers and a range of other vendor and supplier services
Our auditors can provide you with a detailed, balanced report highlighting:
- Company strengths and vulnerabilities
- Recommendations for short-, medium- and long-term remedial actions
- Overall recommendations as to the suitability of the contractor for your needs
When: September 27 - October 1, 2014 Where: Austin, TX Booth: 418 NSF Participation Elaine C. Messa, RAC, FRAPS, President,...
- 3 months ago
The long-awaited Qualified Persons template for declarations concerning Good Manufacturing Practice compliance of active substances and the accompanying guidance have...
- 4 months ago
On July 1, 2014, the Irish Medicines Board (IMB) will change its name to the Health Products Regulatory Authority (HPRA)....
- Tuesday, September 23, 2014
- 8:30am - 5:00pm
- Manchester, UK, United Kingdom
- Tuesday, September 30, 2014
- 8:00am - 5:00pm
- Boston, Massachusetts, United States
- Thursday, October 2, 2014
- 10:00am - 11:00am
- NA, Massachusetts, United States
- Monday, October 6, 2014
- 8:30am - 5:00pm
- York, United Kingdom