The regulatory world for quality management systems (QMS) is changing fast. To succeed in today’s global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.

For more information:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5698

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today’s global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.

For more information and registration:  http://www.aami.org/events/eventdetail.aspx?ItemNumber=5697

The technology known as CRISPR — clustered regularly interspaced short palindromic repeats — has taken the field of synthetic bioengineering by storm. It emerged as a gene-editing tool only five years ago, but has become a familiar presence in the lab.

The benefits of synthetic bioengineering with CRISPR

CRISPR-Cas9, the full name for the editing system that uses the Cas9 enzyme as molecular scissors, cuts DNA at any desired location. CRISPR’s versatility makes it a popular tool for current and future research projects. Engineers and scientists are using CRISPR to modify and repair DNA in single organisms, create cell and animal models to help accelerate disease and clinical research, and develop CRISPR-based gene drives that can disrupt the spread of animal-borne diseases.

For more information:  https://www.aiche.org/chenected/2018/06/editing-genes-one-sequence-time