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Conducting Effective Internal Pharmaceutical Compliance Audits


תאריך: 6 יוני 2017
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  9:00-17:00
עלות: 1,950 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 17280
שפת הקורס: עברית
על הקורס

Led by a highly experienced auditor and using case studies and role play, this interactive workshop will allow participants to practice preparing for audits; provide tips on scheduling; how to listen and educate without getting too involved; reporting findings and ensuring they are effectively corrected.

Course Faculty:
Karen Ginsbury has literally 100’s of audit hours behind her.  Having participated in GMP audits and regulatory inspections for drug product and APIs, GDP, GLP audits, Karen has the ability to place herself in the inspector’s shoes regarding the approach to how best o satisfy an inspector and ensure a good outcome.  From her vast experience Karen will teach you how to conduct an effective internal audit; which warning signs require further investigation and when to stop and move on to a new topic in order to cover the required material in the available time.
Karen Ginsbury is not only an experienced auditor in GMP, GDP and GLP, but has published a book on compliance auditing purchased amongst others by the US FDA.  Ms Ginsbury has a lively and highly interactive teaching style and is known to share her experience with course participants.

קהל היעד

This course is suitable for any person involved in planning, reviewing, performing or responding to or participating in internal audits.  Disciplines include: purchasing, quality assurance, quality control (management of contract laboratories), production personnel who are audited, logistics personnel involved in managing contractors and sub-contractors, engineering personnel auditing equipment providers, IT personnel auditing software and hardware manufactures and management involved in reviewing audit outcomes and verifying implementation of satisfactory CAPA to the audit findings.

התועלת שתופק

At the end of this course, participants will understand the GMP requirements related to conducting audits and will obtain tools for conducting effective audits which result in improvement of the quality system.

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Regulatory requirements for auditing in-house – self-inspection
  • Quality Risk Management applied to the internal audit program
  • (Auditing Suppliers – just a brief discussion)
  • Interactive Exercise: Using QRM to plan audit frequencies
  • Conducting the audit: educating rather than criticizing; listen but be effective – cutting off a lengthy discussion – this is the right way…maybe?
  • Wrap up meeting - do’s and don’ts and commitment to actions
  • Report writing
  • CAPA: how to get effective responses and follow up on implementation of corrective actions; escalation
  • They correct the finding without addressing the root cause(s)?
  • Audit close out
  • Interactive exercise: simulation of an audit: various scenarios

Detailed Agenda

08:30 – 09:00
Registration and Breakfast
 09:00 – 10:30 Regulatory requirements for auditing: ICH Q10, EU chapter 9 self-inspection; QRM in auditing – ARE WE DOING TOO MANY AUDITS?
 10:30 – 11:00
Coffee break
 11:00 – 12:30 Workshop: using QRM to schedule audits; Scheduling and preparing for the audit
REDUCING THE NUMBER – increasing the QUALITY
 12:30 – 13:30 Lunch break
 13:30 – 14:45
Performing an audit with simulation; report writing and presenting findings
 14:45 – 15:00 Tea break
 15:15 – 16:30  Wrap up, CAPA, responses and escalation to senior management
16:00 – 17:00
Workshop wrap up, Q&A
  
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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