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Regulatory Affairs White Papers

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1-15 of 52 results
Do you have a robust and compliant CAPA System?
| By NSF International
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.
Regulatory Affairs > White Papers
How to write to Regulatory Agencies when things go wrong
| By NSF International
Your essential guidance on what to do next after you receive a less than positive regulator's audit report.
Regulatory Affairs > White Papers
NSF asks why Annex 1 is Important to you
| By NSF International
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.
Regulatory Affairs > White Papers
Heightened FDA Enforcement for Sterility Issuesin Pharma Biotech with NSF
| By NSF International
NSF analysed all of the warning letters issued to pharma and biologic manufacturers for sterility issues since 2015. This white paper provides detailed insight into our analysis. It includes relative charts and a table with a summary of the regulations cited by the FDA as well as recommendations for closing your compliance gaps.
Regulatory Affairs > White Papers
NSF: Essential Rules When Investigating GMP Deviations During Sterile Processing
| By NSF International
This white paper by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating pharmaceutical GMP deviations or deficiencies in sterile processing.
Regulatory Affairs > White Papers
NSF Explains the Points to Consider when Auditing a Terminally Sterilised Drug Product
| By NSF International
When conducting an audit of the terminally sterilized pharmaceutical product process, the essential checklist outlined in this white paper by Maxine Fritz will help.
Regulatory Affairs > White Papers
NSF - Site Director: KPIs Should Look Forward as well as Measure Results
| By NSF International
A Site Director expresses his views on how to use KPIs most productively.
Regulatory Affairs > White Papers
NSF asks a Production Director for their views on moving forward with KPIs
| By NSF International
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
Regulatory Affairs > White Papers
NSF determines what KPIs mean for Employees
| By NSF International
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
Regulatory Affairs > White Papers
NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
| By NSF International
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
Regulatory Affairs > White Papers
Tech Talk: CHANGING GMP BEHAVIORS with NSF
| By NSF International
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
Regulatory Affairs > White Papers
NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release
| By NSF International
What are your views on KPIs? Essential or a necessary evil? “They are absolutely essential, providing they are good! I remember during a regulatory inspection I was asked every QP’s most feared question: How do you know everything is in control before you release product?
Regulatory Affairs > White Papers
NSF: Learn from a Fabulously Successful GMP Remediation Program
| By NSF International
This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.
Regulatory Affairs > White Papers
NSF: Remediation of Pharma Quality Systems – It’s All About the People
| By NSF International
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
Regulatory Affairs > White Papers
1-15 of 52 results