Always Inspection ReadyInspection Readiness
Are you ready for a regulatory inspection / customer audit?

Conducted by: Ms. Karen Ginsbury
Categories: Laboratory, Quality
SKU: 20933
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PIC/s The Pharmaceutical Inspection Cooperation Scheme has scheduled a meeting for November 2020 in Thailand on “How to be a Good GMP Inspector.” You need to be ready to be a good GMP inspectee. Are you always inspection ready? Does your company have a corporate culture which requires operations to always be conducted as if an inspector is watching? Or...Continue reading

PIC/s The Pharmaceutical Inspection Cooperation Scheme has scheduled a meeting for November 2020 in Thailand on “How to be a Good GMP Inspector.” You need to be ready to be a good GMP inspectee.

Are you always inspection ready?

Does your company have a corporate culture which requires operations to always be conducted as if an inspector is watching? Or is it a ghastly scramble, repaint, move equipment to a caravan outside in the yard as soon as the inspection date is notified.

What if…unannounced inspections become the norm? Will your company still be allowed to produce? Actually, unannounced inspections already are the norm.
This course will help you to understand the concept of “always inspection ready” as a quality system advantage and company culture. What are the challenges to overcome and how to show case your quality system in a short time for a positive inspection outcome.

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Date:  2 December, 2020
Course location: Bioforum Offices, 3 Golda Meir st., 4th Floor, Weizmann Science Park, Ness Ziona
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: 1,850 NIS + VAT
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Issues to be covered

  • Inspection Findings and Approaches: Plan – Do – Check- Act
    • MHRA, FDA 483s and warning letters: what’s hot, what has changed?
    • FDA Guide: Circumstances constituting refusal, denial, or delay of inspection
    • FDA New Inspection Protocol Project (NIPP)
    • Quality Culture Assessments: FDA vs MHRA approach
    • Quality Metrics: altering behavior vs unintended consequences
  • What are good metrics for “always inspection ready”
    • GMP/GxP vs a continually improving PQS (Personnel Qualification Standard)
    • Context of Your organization
    • Process Mapping, QRM (Quantitative Risk Management), Data Governance
  • Competent Subject Matter Experts (SMEs)
    • How do you become competent and what does it mean: regulatory intelligence and updating
    • PIC/s Inspectors Academy: Inspection Excellence through Harmonized Training
    • CV vs Job Description vs Training vs Skills / Function Matrix
    • Familiarity with material – hands-on
    • Briefed in presenting
    • Prepares summaries of complex topics / deviations / changes
    • Revises constantly – internal audits challenge SMEs (Subject-Matter Experts)
    • CAPAs for audits including coaching SMEs, including mock inspections
  • Mock Inspection: Inspection Do’s and Don’ts – Learn Through Doing
    Using real-life case studies and inspection transcripts (anonymous) collected through years of consultancy, this facilitated workshop allows participants y to test their skill at answering questions and presenting topics as SMEs.  The mock inspection is a participant favorite.  Those watching pick up “do’s and don’ts.” Behavior and responses are reviewed to learn how to do better in the real inspection.  Inspection Handling SOP is discussed
  • Always Ready QMS (Quality Management System): What does it REALLY mean?
    • Prevention: Practical, applied Risk Management
    • Reaction for future prevention: Deviations and investigations
      • Eliminating the cause of unwanted, unexpected, undesirable events
    • How to Evaluate / Demonstrate the Effectiveness of a PQS in relation to Risk-based Change Management: PIC/s 2019 draft guide NEW GUIDE
    • WHO Data Integrity Guide 2019 NEW GUIDE
    • DIRA: Data Integrity Risk Assessment
    • Product Quality Review / Annual Product Review vs Continued Process Verification
    • Lifecycle management: ongoing verification of process and analytical methods

Who should attend

This course is suitable for:

  • Anyone working in the pharmaceutical industry who will be part of a regulatory inspection
  • Executive Management
  • Subject Matter Experts (SMEs)
  • QPs
  • Quality Assurance
  • Quality Control
  • Other Quality Unit professionals
  • Operations and Product Managers
  • R&D
  • Technology Transfer
  • API and finished product manufactures
  • Distributors
  • Brokers
  • Wholesale dealers or involved in the handling,processing or sale or administration of any of these

Benefits to the Participants

Participants will come away from this course

  • Understanding the stress the inspector faces and will have a more focused approach to a regulatory inspection
  • Appreciating the inefficiency of “preparing” for inspections, and the inherently better and cost-saving quality system which is “always ready” will allow a cultural shift
  • Through understanding the regulator and FDA’s NIPP inspection program, participants will be better able to navigate the pre-inspection requests as well as having documents at their finger-tips to present to the inspector during the audit
  • A subsidiary but far from trivial additional benefit: Customer audits, internal audits and vendor audits will all be more effective and better managed

About The Lecturer

Karen Ginsbury
B.Pharm, M.Sc, MRPharmS, has over twenty years of experience in
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