New

Supplier Audits including workshop

Conducted by: Ms. Karen Ginsbury
SKU: 241124
Print version

Share a colleague:

Led by an experienced auditor, using case studies and role play, this interactive course / workshop allows participants to practice auditing; provides tips on scheduling; teaches what to ask; how to manage time on site; wrap-up meeting; reporting findings and following up on correction.

Led by an experienced auditor, using case studies and role play, this interactive course / workshop allows participants to practice auditing; provides tips on scheduling; teaches what to ask; how to manage time on site; wrap-up meeting; reporting findings and following up on correction.

Close
Date:  4 June, 2024

מתעניינים? לחצו כאן

    Course location: Hybrid: Kiryat Weizmann Ness Ziona or ZOOM
    Duration: 1-Day Course
    Hours: 09:00 - 17:00
    Credits: 1
    Course Language: עברית

    Course price: €651 + VAT
    Early registration is Closed
    Do you have a subscription? You deserve more

    Have a question? We got all the answers

    Issues to be covered

    Regulatory inspection findings and requirements at suppliers / manufacturers / brokers

    Scheduling audits using risk-based thinking

    The audit agenda:

    • Documents to ask for ahead of the audit
    • The audit on site
    • Preparing for and conducting the wrap-up meeting

    Conducting the audit: educating instead of criticizing; listen but cut off long

    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

    What happens if 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 – 10:00 Inspection findings and regulatory requirements for supplier audits: ICH Q10, EU chapter 5; 21cfr 211?
    10:00 – 10:30 Scheduling audits: risk-based thinking
    10:30 – 11:00 Coffee break
    11:00 – 12:30 Audit agenda
    12:30 – 13:30 Lunch break
    13:30 – 14:450 Simulate audits in small groups each with a case-study to discuss and work through – present findings to class
    14:45 – 15:00 Tea break
    15:15 – 16:30 Wrap up meeting, report, responses and escalation
    16:30  – 17:00 Workshop wrap up, Q&A

     

    Who should attend

    This course is suitable for any person involved in managing, planning, reviewing, performing or responding to or participating in GMP supplier audits.  Disciplines include: purchasing, quality assurance, quality control, production personnel, logistics personnel and management involved in reviewing audit outcomes and verifying implementation of satisfactory CAPA to the audit findings.

    R&D personnel involved in supplier selection for new products may find the course of value.

    Benefits to the Participants

    At the end of this course, participants will understand how to audit suppliers for compliance with cGMP and will have tools to conduct efficient audits for improved supplier communication and management.

    About The Lecturer

    Karen Ginsbury
    B.Pharm, M.Sc, MRPharmS, has over twenty five years of experience
    Read more
    תחזוקת מערכת האיכות בזמן מלחמה QMS

    Leave a Reply



      [anr_nocaptcha g-recaptcha-response]