Laboratory
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..
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..
Case Studies on Failed Cycles and/or Formulations of Lyophilized Products
This webinar will initially give a background on the basics of freeze-dried products and the freeze-drying process. Special attention will be given to the thermal properties of a product (glass transitions, eutectic melts, etc.), and how these properties are affected by heat, residual moisture, and different excipients. Several case studies in failed freeze-dried products due to poorly designed cycles, and ..
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..
Complaint Management: Best Practices to Assure Compliance and 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..
Contamination Controls for Non-Sterile Drug Product Manufacturing Facilities
This presentation is intended as an introductory overview of current industry best practices for minimizing the risk of non-sterile drug product contamination during the manufacturing process. A brief overview of the primary regulatory requirements and industry standards will be presented, (FDA, EU, ISO, ICH, USP, PDA, USP), followed by presentation and analysis of 3 differing approaches for contamination c..
Data Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..
De Novo Classification Process
Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III to Class ..
Developing an Effective CAPA Management and Root Cause Analysis System
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which..
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out. This is necessary to protect against the onslaught of threats and attacks, both from natural disasters ..
Effective and Practical use of FMEA for Risk-Based Approach to Computer Systems Validation
Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. One way to avoid these issues is to ..
Equipment Validation, Tracking, Calibration and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a product ..