{"product_id":"quality-risk-management-a-practical-guide-copy","title":"Conducting Compliant Investigations – 2nd edition","description":"\u003ch3\u003e\u003cspan style=\"text-decoration: underline; color: rgb(223, 22, 22);\"\u003eNew Title - publication date October\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cbr\u003e\u003cstrong\u003eEditor: Jeanne Moldenhauer\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eISBN:   ebook – 978-1-917195-24-9    800pp   £240\u003cbr\u003eISBN:  Hardback – 978-1-917195-25-6    800pp  £270\u003c\/p\u003e\n\u003cp\u003eThis book provides many different approaches to conducting compliant investigations, where compliant means that they will meet the requirements in the applicable regulatory documents.  This new 2nd edition expands on the first edition of 2021 and includes eight extra chapters that cover the topic in even greater depth. It provides invaluable information on conducting investigations that will be acceptable to regulatory investigators and that can lead to significant regulatory risk reduction.\u003c\/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003cstrong\u003eJeanne Moldenhauer\u003c\/strong\u003e is Vice-President of Excellent Pharma Consulting and has more than 30 years’ experience in the pharmaceutical industry.  She chaired the Environmental Monitoring\/Microbiology Interest Group of PDA for more than 15 years, served on the Scientific Advisory Board of PDA for many years, founded the Rapid Microbiology User’s Group™, is a member of ASQ and was a member of RAPS for many years.  She is the author of numerous books including: Steam Sterilization: A Practitioner’s Guide, Laboratory Validation: A Practitioner’s Guide, Environmental Monitoring: A Comprehensive Handbook (Volumes 1-9), System’s Based Inspections for Pharmaceutical Manufacturers, Preparing for an FDA Inspection Review of Warning Letters (Sterile and Non-Sterile), co-author of Biological Indicators, and many others and numerous publications (Book Chapters and Magazine Articles).\u003c\/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003cstrong\u003eChapter titles and authors\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e1.    Introduction – Jeanne Moldenhauer\u003cbr\u003e2.    Why Do Investigations (Regulatory Requirements for Investigations) – Jeanne Moldenhauer\u003cbr\u003e3.    Regulatory Observations Relative to Investigations in USA – Jeanne Moldenhauer\u003cbr\u003e4.    Regulatory Observations in EU – Tim Sandle\u003cbr\u003e5.    Background on Deviations and Investigations – Jeanne Moldenhauer\u003cbr\u003e6.    Planning the Investigation – Jeanne Moldenhauer\u003cbr\u003e7.    Root Cause Analysis – Jeanne Moldenhauer\u003cbr\u003e8.    Root Cause Analysis Tools (Quality and Engineering Tools) – Jeanne Moldenhauer\u003cbr\u003e9.    Laboratory Investigations Microbiology – Tim Sandle  \u003cbr\u003e10.    Laboratory Investigations – Chemistry  –  Paula Shadle\u003cbr\u003e11.    Personnel Monitoring and Handling Investigations – Marsha Steed\u003cbr\u003e12.    Production and Utility Investigations – Jeanne Moldenhauer\u003cbr\u003e13.    Sterilization Failure Investigations – Jeanne Moldenhauer\u003cbr\u003e14.    Labeling Investigations – Jeanne Moldenhauer \u003cbr\u003e15.    Documentation Error Investigations – Jeanne Moldenhauer\u003cbr\u003e16.    Data Integrity: Data Integrity Issues – Jeanne Moldenhauer\u003cbr\u003e17.    Sterility Failure Investigations – Tim Sandle\u003cbr\u003e18.    Media Fill Failures – Jeanne Moldenhauer\u003cbr\u003e19.    Environmental Failure Investigations  Karen Ginsbury\u003cbr\u003e20.    Vendor and Contractor Investigations – Rick Jakober\u003cbr\u003e21.    Complaint Investigations – Jeanne Moldenhauer \u003cbr\u003e22.    Stability Failure Investigations –  Jeanne Moldenhauer\u003cbr\u003e23.    Determining the Product Impact Analysis asked – Siegfried Schmitt\u003cbr\u003e24.    How to Write a Good Investigation Report – Jeanne Moldenhauer\u003cbr\u003e25.    Tracking and Trending Requirements – Jeanne Moldenhauer\u003cbr\u003e26.    Automated Systems for Tracking Systems\/Deviations – Jeanne Moldenhauer\u003cbr\u003e\u003c\/p\u003e","brand":"Euromed Communications","offers":[{"title":"Hardback","offer_id":58546951160189,"sku":null,"price":270.0,"currency_code":"GBP","in_stock":true},{"title":"e-Book","offer_id":58546951192957,"sku":null,"price":240.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0091\/8172\/4757\/files\/CCI-2nd-ED.jpg?v=1786966410","url":"https:\/\/euromedcommunications.com\/products\/quality-risk-management-a-practical-guide-copy","provider":"euromedcommunications","version":"1.0","type":"link"}