Pharmaceutical
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..
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..
Cleaning Validation
This webinar discusses global Cleaning Validation as it is implemented in the pharmaceutical and biopharmaceutical industries. In addition, it describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to the lifecycle of the product manufacturing process. Establishing health-based Cleaning Validation limits also discussed in this session. Addit..
Clinical Process Improvement
Effective process improvement can be key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. Likewise, the contract research organization (CRO) level or the institutional review board (IRB) level can have serious downstream effects, negatively impacting study efficacy and time-to-market. It is essential, therefore, that all participants in cl..
CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:EU GMP Chapter 7 "Outsourced Activities" January 2013Guidance for Industry -..
Comparability Protocols for approved drugs
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable the completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.Learning ObjectivesA..