How could one assess the effectiveness of a Quality Management System?The best way to do that is by using the ultimate transfer unit: MONEY!The purpose of a firm is to make Money, the purpose of a QMS is to enable the firm to produce, and therefore – generate money with minimum losses that are reflected by failures.The principles are known, but it is done?This lecture will give the listener the basic know-h..
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..
When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge..
In many companies, deviation/non-conformance investigations are often criticized for the lack of a robust root cause analysis. The proper root cause can help a company in many ways. Root cause analysis helps identify what, how and why something happened, thus preventing recurrence. Root causes are underlying, are reasonably identifiable, can be controlled by management and allow for the generation of recomm..
Today, any new medical device that is found not substantially equivalent for a reason other than performance data not previously classified based on risk is “automatically” or “statutorily” classified as a Class III device. This occurs because, by definition, a new device type would not be equivalent to a device type on the market before the 1976 Medical Device Amendments were placed in force or that has si..
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus..
This training will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation.It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation. Domestic and international regulations contain the requiremen..
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them.Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems..
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to ha..
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for. Anyone in a medical device se..
This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.This course will provide attendees with the proper tools and information to build a robust change contr..
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..
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrenc..
The need for GMO labeling has been a hot topic for over 15 years. Scientific inquiry regarding the safety of GMO products has generated more questions that have been answered and has added fuel to the controversy.After extensive review and industry input, the National Bioengineered Food Disclosure Law) PL114-216) was signed into law on July 2016. The rules impact many types of food including beer, dai..
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 -..