Industry News
Join the MWA and AVS Life Sciences Team at these upcoming industry events:
ISPE 31st Annual Vendor Night Exhibit Show, March 14, 2024, at Oracle Park in San Francisco, CA
Pharma MES USA, March 20-22, 2024 in San Diego, CA
All Star Project-Becoming All Stars 2024, March 23, 2024 in Hayward, CA
American Biomanufacturing Summit, April 10-11, 2024 in San Francisco, CA
ISPE Bay Area Chapter: Bayer Facilities Tour, April 11, 2024 in Berkeley, CA
Diversity Alliance for Science-East Coast, April 30-May 2, 2024 in Newar NJ
32nd Annual ISPE DVC Symposium and Exhibition, June 18, 2024 in Philadelphia, PA
FDA Launches Pilot Program to Support Rare Disease Drug Development
FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel efficacy endpoint development for drugs that treat rare diseases. The RDEA Pilot Program fulfills a commitment under PDUFA VII. The RDEA Pilot Program is designed to: Seek to...
MWA to Present at the Masters Summit in Salt Lake City
MWA team members Sumaiya Reza, VP of Client Services, and Lisa Helmonds, VP of Quality and Operations, will be attending the Masters Summit Conference October 24-28, 2022 in Salt Lake City, UT. Don’t miss their breakout session October 25th on Business Leadership –...
The Criticality of Supplier Management and Keys to Improvement
Posted September 29, 2022 on GXP Lifeline/MasterControl. This article by MWA team members Lisa Helmonds and Myrna Russell will help you learn how to simplify and strengthen your supplier management program. Read more here.
MWA welcomes Alyssa Woolard as Client Services Manager
MWA is pleased to announce that Alyssa Woolard has joined our team as Client Services Manager. Alyssa has over ten years of experience in the pharmaceutical industry including roles in quality control, project management, business development, and contract management....
FDA Proposed Rule: Quality System Regulation Amendment
On February 23, 2022 the FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) to incorporate the international standard specific for...
Center for Devices and Radiological Health (CDRH) Issues 2022-2025 Strategic Priorities
FDA’s Center for Devices and Radiological Health (CDRH) announced its 2022-2025 Strategic Priorities. The center established clear goals and measures of success for the overarching device program and each strategic priority. CDRH’s measures of success will show the...
Remote Auditing: Three Keys to Success
This article was originally published in March 2021. Remote audits will continue to be the norm for 2022. While not always ideal, remote audits can be conducted effectively under the proper circumstances. This article can also be read on MasterControl’s GxP Lifeline....
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry
FROM THE INTRODUCTION: Visible particulates in injectable products can jeopardize patient safety. This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development,...
FDA Announces Availability of Portal and draft Guidance on Reporting Amount of Listed Drugs and Biological Products
FDA has announced the new use of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for...
FDA Issues New Draft Guidance on Sponsor Responsibilities for Safety Reporting Requirements and Safety Assessment in Certain Research Studies
The U.S. Food and Drug Administration has issued the draft guidance for industry, Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability (BA)/Bioequivalence Studies (BE). This guidance merges content from the final...