Life Sciences
Refine Search
Analytical Techniques For Enhancing Supply Management Performance
Supply Management is about buying the right thing, at the right time, at the right quality, at the right price, from the right supplier, in the right way. In order to do these steps “right” requires skillsets in many analytical techniques. This webinar covers some of the basic analytics that purchasing and contract personnel use to obtain maximum value for their organizations. Show how Purchasing Savin..
Answering and Replying to an FDA 483
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..
Auditing Basics and Fundamentals for Medical Devices and Drugs
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the acc..
Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning Obj..
Automating Assays for Clinical Diagnostics
Laboratories need to transition technologies all of the time. From new ways to perform assays to outdated technology, to new equipment pushes to the various needs of end-users, assays need to switch between technologies on a regular basis. One needs to be able to easily and robustly transition assays from one technology to another. With this seminar, you will be able to fully understand how your essay is cu..
Batch Record Review and Product Release
This webinar will analyze each of these necessary elements of the batch record review process.Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in ord..
Best Practice for Complaint Handling to Assure Customer Retention
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..
Best Practices for a Compliant, Lean Supplier Management Program
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that yo..
Best Practices for Implementing an Effective Cleaning Validation (using principles of upcoming ASTM E3106)
This webinar discusses the implementation of Cleaning Validation programs based on global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. What makes this webinar special and unique is a very rare glimpse into upcoming ASTM E3106 for Cleaning Validation. This is a Risk-Based Science-Based Lifecycle approach guidance document that was fully v..
Best Practices For Investigating Deviations
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum..
Best Practices for Managing an FDA Inspection
Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your qu..
Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach
This webinar will highlight difficulties in obtaining relevant and useful dissolution results based on current practices. This will be followed by the description of principles of drug dissolution testing leading to a simple and common set of experimental conditions reflecting a bio-relevant method. The discussion will be presented describing that the suggested bio-relevant method would become a QC method a..
Building a Compliant Laboratory – From Foundation to Business Excellence
Compliance in laboratory settings has been a topic for the FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business. In this presentation, I will define compliance, provide a translation of regulati..
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's a..