All FDA Regulated Industry
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..
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. In this webinar, ..
NOM-051-SCFI/SSA1-2010, General Labeling Specifications For Pre-packaged Foods and Non-alcoholic Beverages-Commercial and Sanitary Information
General Mexican labeling specifications for pre-packaged foods and non-alcoholic beverages have been submitted to different changes due to health policies in Mexico. In order to comply with the new guidelines, you’ll need to include in your label the warning seals for critical nutrients.Receive the most up-to-date information first-hand from an industry expert that collaborated through the ICC in the most r..
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommendations to assure that in addition to being able to illustrate compliance, your firm’s CAPA system is useful and meaningful. CAPA is th..
Cosmetics and OTC products that are intended for use in healthcare settings are being used by individuals that are vulnerable to opportunistic pathogens. Products including lotions, creams, toothpaste, mouthwash and mouth moisturizers are commonly given to patients for their personal use while in the hospital. Other products like surgical preparations and shared hand creams for workers can become contaminat..
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 ObjectivesIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrat..
This webinar will provide a basic foundation for Good Manufacturing Practices essentially for any medical marijuana production operation. Medical marijuana growing and production is a regulated industry and is becoming more regulated every day. GMPs pertain to medical marijuana just as they do to pharmaceutical, medical device biologics, foods, etc. Unfortunately, there is no unified standard as to how they..
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories, and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system. This training session will cover the US Pharmacopeia Genera..
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize product defects and also the risks associated with the manufacturing of the pharmaceutical product.Areas Co..
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 InspectionsPrepa..
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors. A key component of this webinar is the discussion of the..
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and the system meet all required regulations, especially for critical suppliers.This webinar will review the QSR and ISO requirements for supplier evaluation, including defin..
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, ..