עדכוני GxP של הרשויות באירופה ובארה"ב

GxP Updates – FDA, PIC/s and ICH

תאריך: 19 ינואר 2015
מיקום הקורס: כפר המכביה, רמת גן
קטגוריה: איכות
מידע כללי
משך הפעילות: יום לימודים מלא
שעות: 9:00-17:00
עלות: 1,950 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 15470
שפת הקורס: עברית
על הקורס

ICH Q11 has just been adopted by FDA and EMA.  A guideline on the development of APIs, Q11 is a parallel document to ICH Q8: Pharmaceutical Development for finished pharmaceuticals.  ICH Q10 is long finalized (Pharmaceutical Quality System) as is the Quality Risk Management ICH Q9.  Chapter 1 of the EU GMPs has changed to the “Pharmaceutical Quality System” and addresses root cause analysis and CAPA as well as management responsibilities and outsourced activities along with revised chapter 7.  Annex 2 on biological products has been expanded to address new therapies such as transgenic products and gene therapy, monoclonal antibodies and is now over 30 pages in length.  The Israeli Ministry of Health has signed an ACAA with the EU – what does it mean for local companies.
And then learn how parts of the “voluntary” guides are actually compulsory in the body of updated chapters 1 – 9 and some of the annexes.  Learn about the Inspector’s Working Group and their annual workplan which includes revision of the Good Distribution Practices regulations as well as almost every chapter of the EU GMPs
And then learn how FDA avoids updating the CFR (their GMPs) by writing guidances and enforcing them despite their being “non binding regulations.”
And then learn where PIC/s, ICH, ISO and USP fit into this picture.

קהל היעד

This is a course suitable for anyone working in a pharmaceutical company.  Since it will encompass the entire spectrum of GMP regulations, it is suitable for both advanced level personnel needing an update and refresher as well as entry level personnel from the following groups:
Production and operations; maintenance and engineering; quality control, quality assurance /quality unit, regulatory affairs, validation personnel; supply chain and purchasing managers and any other person working in a company with GMP related responsibilities.

עדכוני GxP של הרשויות באירופה ובארה"ב
התועלת שתופק

This course will fulfill your requirements for the annual GMP refresher which you need to remain familiar with the requirements pertinent to your job function.  By participating you will ensure that you are up to date not just with current regulations but with regulations and guidance in the making.  You will be able to proactively plan improvements to your quality management system to reduce deviations and non conformances and ensure positive inspection outcomes.

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Overview of current GMPs and the regulatory climate in the EU and US
  • EU 2012 Work-Plan for GMP / GDP Inspectors Working Group
  • FDA Guidances - status
  • Recent warning letters and inspectional findings
  • ICH Q10 Pharmaceutical Quality System and revised Chapter 1 together with draft of chapter 2 of EU GMPs (Quality Management System and Personnel)
  • Dedicated Facilities vs Multiproduct Facilities: existing and draft GMPs in EU and US including Chapter 3 on Premises and Equipment and Revised Annex 2 on Biological Products
  • Chapters 4 and 5: Documentation and Production
  • Draft chapter 5 on Supply chain and US FDA concerns with supply chain
  • Chapter 7 – Outsourced operations / contract manufacture, contract testing and other outsourced activities and quality agreements
  • Updates to chapter 8 (complaints and recalls) and Good Distribution Practice regulations as well as some of the annexes (Qualified Person and batch release, Annex 16) and Annex 15 Qualification and Validation with FDA new Process Validation Guide
  • Questions and answers – course close-out
אודות המרצה

גב' קרן גינסבורי

M. Sc. B. Pharm. MR PharmS. בעלת ניסיון של למעלה מעשרים שנה בתעשייה הפרמצבטית.
בוגרת תואר ראשון ברוקחות ותואר שני במיקרוביולוגיה מאוניברסיטה של לונדון.
קרן החלה את הכשרתה המקצועית בתעשייה הפרמצבטית במחלקת המו"פ של חברת Smith & Nephew באנגליה. מאז ועד היום היא ממשיכה את דרכה בתעשייה הביו-רפואית
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