Food and Dietary Supplements
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..
EU Medical Devices Regulation: The Practice
The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class, participants will be introduced to the new requirements in the Medical Device Regulation (MDR), inc..
Implementing a Change Control Quality System Successfully
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..
The FDA Inspection: Best Practices for Preparation, Behavior, and Response
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&..
Trends in FDA Compliance and Enforcement for Regulated Systems
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 ..
2019 Safe Food For Canadians Regulations
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..
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
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..
2020 Safe Food for Canadians Regulations
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, ..
21 CFR Part11 Compliance
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..
5S for Operators
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..
Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks
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..
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
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..
Advertising and Promotional Material Compliance and Review Process
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..
Allergen Cleaning, Validation & Preventative Risk Management
Allergens are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods. It is the largest area for recalls in the US and growing at a staggering rate. Anyone wanting to know how to approach, improve or review their Allergen Management Program should participant to understand the latest information for Best Practice preventative controls. Important elements will inc..
Answering and Replying to an FDA 483
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..