We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization. Why should you Attend: Because as much as we try, most regulated industries don't have a set approach for developing a compliance program that is integrated into the fabric of their organization, that serves real valuable functions to improve operations, improve and maintain human competenc...

Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program. Areas Covered In the Session: Discuss what FDA is...

FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns. Areas Covered in the Session: Learn the pre-selection, selection and assessment process through the use of various tools Methods, techniques and strategies that work and are proven with supplier relations and qualifica...

Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matter of if an attack will occur, only when. Why should you Attend: A poor response is often more damaging that the cyber-attack itself. According to recent reports, cyber-attacks cost the average American business $15.4 million per year...

This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. Why should you Attend: FDA and ISO call for change control but do not provide any further guidance as to how to create a compliant system. The situation gets complicated when a company has suppliers or contract manufacturers and chan...

Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning. Why should you Attend: This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a clean room e...

There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under...

This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System documentation. Areas Covered in the Session: History and background Types Organization Requirements Regulatory expectations Maintenance Who Will Benefit: Compliance Personnel QA Personnel Validation Personnel

Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results based on statistical database for each batch of that product code. Strategies for process control and operator activities can be designed to reduce variation, adjust for variation during manufacturing and reduced possibil...

Becoming accredited is a verification of the laboratory's capability of producing reliable results in accordance with the requirements of ISO/IEC 17025. Accreditation is not a guarantee of analytical competency. Getting accredited is just the beginning. The journey begins with defining the laboratory's operating principals and policies. It continues with describing the procedures that will be implemented to address these policies and it will c...