Food and Dietary Supplements
Compliance documentation to include Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purp..
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus..
This webinar will include discussions on 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 ObjectivesDiscuss what to do when problems occurOutline the requirements of the CAPA process a..
A medical device or biotechnology startup plant needs to have products available yet be agile enough to respond quickly to demand and design changes without wasting excess inventory, especially from obsolete products that did not pan out. This webinar explains how to set up and use kanbans all the way from Purchasing and Procurement, to Receiving, Receiving Inspection, Component Stock, Work Order Picking/St..
NMX-F-605-NORMEX-2016 Foods–hygienic Handling In The Service Of Prepared Food To Obtain The “H” Distinctive
Distinctive H is the recognition granted by the Ministry of Tourism, with endorsement by the Ministry of Health, to fixed establishments of food and beverages for complying with the Hygiene and Quality standards established by the Mexican Standard NMX-F-605-NORMEX.The causal dangers of foodborne diseases can come from the different stages that exist along the food chain (from primary production to table..
A complete and effective employee training program must be in place to assure training requirements are established, implemented, and verified. This session will instruct attendees on the regulatory requirements of personnel training, and the establishment of a the training program, including new employee training, methods of training, how to document training so that it is readily available for r..
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 10..
This webinar will review how best to approach biosafety and implement an effective management program for blood-borne infections, safety and health, laboratory safety, infectious material, and blood infection. If you work in a laboratory exposed to viruses or bacteria that are biological hazards and are searching for a better way to manage your Biosafety program, this webinar will help give you the framewor..
This Official Mexican Standard establishes the minimum requirements of good hygiene practices that must be observed in the process of food, beverages, or food supplements and their raw materials, in order to avoid their contamination throughout their process.The causal dangers of foodborne diseases can come from the different stages that exist along Among the good manufacturing practices included in NOM-251..
The specifications for the electronic drug establishment registration and drug listing information required by FDA are generally defined in the Health Level 7 (HL7) Structured Product Labeling (SPL) document mark-up standard. Further, the HL7 SPL document mark-up standard provides compliance details about minimum requirements for the structure and semantics of the content of authorized published information..
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. New approaches to software validation will help avoid many of the structural costs with a major endeavor by removing legacy methods that applied to paper systems. This will also set the stage for further integratio..
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes the development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCo..
The extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to be used during a GMP audit. The auditor can begin to understand the areas wh..
While capsules themselves are a simple concept, understanding the most effective ways to utilize them are not. From unique dissolution profiles to differing oxygen protection, and even targeted delivery, the form of capsule your company uses is paramount to creating the most effective product possible. Come learn about why HPMC and Pullulan will be the capsules of the future, how they differ from gelatin, a..
The outcome of regulatory inspections is critical to an organization’s success. If the outcome of the inspection results in FDA 483 observations or a warning letter, it is important to take the observations and subsequent responses very serious. This course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, edu..