Revised PIC/S GMP Guide Marion Weinereb & Associates, Inc. email linked in twitter facebook Consulting and Staffing Expertise in Quality Systems and GXP Compliance Home About MWA... Corporate Information Leadership Project Experience Strategic Partnerships Testimonials Services MWA Services Training News Resources Careers Contact Us MWA Newsletter Signup close... News Revised PIC/S GMP Guide The revised PIC/S GMP Guide (PE 009-10) was adopted by the PIC/S Committee in October, 2012. The revisions involve Part I with GMPs...

GMP News: New EMA Guideline... Marion Weinereb & Associates, Inc. email linked in twitter facebook Consulting and Staffing Expertise in Quality Systems and GXP Compliance Home... About MWA Corporate Information Leadership Project Experience Strategic Partnerships Testimonials Services MWA Services Training News Resources Careers Contact Us MWA Newsletter... Signup close News GMP News: New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation The EMA just released a draft guideline on dedicated facilities...

About MWA Corporate Information Leadership Project Experience Strategic Partnerships Testimonials Services MWA Services Training News Resources Careers Contact Us MWA Newsletter..., and biotechnology industries through innovative and holistic solutions. MWA offers a full range of consulting services in GCP, GLP, and GMP compliance. MWA provides consulting expertise from... consultant who helped us at Isis Pharmaceuticals in preparing for the pre-approval inspection of our first product. Marion brought her expertise in QA oversight of GMP...

Home About MWA Corporate Information Leadership Project Experience Strategic Partnerships Testimonials Services MWA Services Training News Resources Careers Contact Us MWA Newsletter... Service Descriptions Training Sitemap NewsCMC Working Group issues Quality by Design (QbD) Case Study for Vaccines Risk takes a new dimension : PIC/S Aide-Memoire 510(k) Device... Quality GCP News: MWA Offers Consulting Expertise in Good Clinical Practices GMP News: New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation...

Corporate Information Leadership Project Experience Strategic Partnerships Testimonials Services MWA Services Training News Resources Careers Contact Us MWA Newsletter Signup close... to the draft rule issued by FDA a few years ago. For certain classes of combination products, companies have the choice of complying with either all of the GMP requirements for both... components (drug and device, or biological and device) or taking a streamlined approach whereby the company documents compliance with either the drug GMPs or the QS regulations along...