All FDA Regulated Industry
Risk Management - Implementing ISO14971: 2019
Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis.The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical devices products.This process has been streamlined within ISO14971 standard and has become the best practice to show application of a risk-based approach to implementation..
Best Practices for Deviation Training
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning Objectives Discuss what to do when problems ..
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
This session will include the requirements for all required cross-functional responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "no..
Best Practices in Preparation for an FDA Computer System Audit
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..
Equipment Qualification and Validation of Processes
The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writ..
Achieving Compliance with Proper CAPA Systems
This webinar will include discussions, proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions, and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track. Learning Objectives Discuss what to do when problems occurOutline the requirements of the CAPA process and proc..
How FDA Trains Its Investigators to Review CAPA, and Best Practices for Industry Preparation
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used the FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which ..
Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management, and post-marketing surveillance. You should..
Supplier Management: Challenges and Opportunities
Notified bodies and the FDA cannot require your suppliers to meet 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 meets 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 you h..
Effective Batch Record Review
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 order to properly document all critical processing parameters that go along with the production an..
Computer Validation: Methodologies and Approaches for Greater Innovation and FDA Compliance
Advancements in technology have forced organizations to rethink their business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation and maintaining ..
Understanding Aseptic Technique and Cleanroom Behavior
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. This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that..
The FDA Inspection: From SOP to 483
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of InspectionsPreparationDedic..
Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used ..
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.We will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from traditional Comp..