All FDA Regulated Industry
This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software
Advancements in technology have forced organizations to rethink 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 a sy..
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 a..
This course 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.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.There are many forms of cybersecurity a..
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 the 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 InspectionsPreparation&..
FDA requires that all computer systems used to produce, manage, and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the ..
The new standards will be covered in this session encapsulating everything industry needs to know on launching the SFCR.Understanding SFCR and HistoryLicensingPreventative ControlsImportingExportingPortal Overview and ResourcesCompliance Timelines for ImplementationNew Food Safety Regulation to process, import or export foods.Learning ObjectivesBackground on SFCRGuidance ResourcesProvincial TradingForeign S..
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
Safe Food for Canadians Regulation (SFCR) kicked off January 2019 after several long gazette comment periods by the CFIA (Canadian Food Inspection Agency). This session delivers a broad overview of the standard and covers resources for compliance. Under this regulation, many food companies are now required to register for a license, with many aspects mimicking the new FDA FSMA requirements. The new portal, ..
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..
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. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..
Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills. A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification (which is unfeasible in an industry that generates large volum..
This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Advers..
The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..