Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers
Regulators are focused on manufacturers’ quality issues. You only need to look into the issuance of global guidance documents over the past few years: they consistently link data integrity and quality issues/quality culture.
Are you conducting effective audits? Whether your product is on the market or in development, your processes and your business must run smoothly. You can also ensure compliance when you are able to identify and correct these issues before they impact your operations.
Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers will help you prepare, organize and streamline your audit approach so you can identify quality issues to establish a more robust operation that stands up to regulatory scrutiny. This management report points to five important areas of focus — data integrity, quality culture, aging facilities, investigating manufacturing problems and risk management — in auditing to ensure quality.
The management report explains the key factors that identify a quality manufacturing operation and those that call out quality failures:
- Understand the definition of and how to evaluate a culture of quality
- Implement principles of data integrity in manufacturing
- Utilize a risk-based approach to audits
- Recognize warning signals that your culture of quality is slipping
- 55 attributes of a mature quality culture
- Know what steps to take when a quality issue is identified
- Recognize impediments to modernization
- Implement best practices for documenting and tracking resolutions to identified problems
- Understand principles of quality risk management set by ICH, FDA, WHO and other authorities
Use risk-based approaches to manufacturing audits and you’ll identify and mitigate quality issues before they impact business operations. Order your copy of Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers today.
About the Contributor
Susan Schniepp has 40 years of quality assurance experience in the pharmaceutical industry. She served in leadership roles at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott and Hospira. She has earned several awards from the Parenteral Drug Association (PDA), including its Distinguished Author Award, Distinguished Service Award and Gordon Personeus Award. Her publications include the book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process for which she was awarded the 2007 PDA Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers. She has served as a member of the PDA Board of Directors from 2011 to 2013 and from 2016 to 2019 and is the chair-elect starting in January 2020. Ms. Schniepp has served on numerous planning committees for PDA including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working with other PDA members on a technical report relating to manufacturing data integrity issues as well as participating in PDA’s standard-setting activity regarding purchasing controls. In addition to her PDA activities, Ms. Schniepp is an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International magazines.
Who Will Benefit
- Quality assurance ersonnel
- Operations managers
- Senior-level executives
- Regulatory/compliance professionals
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