The FDA inspects facilities, online marketing collateral and physical products to determine compliance with the 21 CFR Part 111 dietary supplement regulations. It is very helpful to review their observations to infer what their priorities are and where industries and companies alike can improve.
In this webinar you will learn how to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can prevent occurrences.
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Attention Food Manufacturers, attend this webinar to learn latest FSMA based strategies to navigate the complexity under Prop 65. Prop 65 is an ever-changing regulatory arena, with complex requirements, frequent legal actions and strict labeling and notification regulations.
During this program, our experts will outline the roles of each team member in the rounding process as well as alternate communication strategies such as care conference, huddles, and internal transfers. Also included will be strategies for planning rounds and how to script team members to optimize time spent discussing each patient.
This webinar will provide an in-depth understanding of anti-kickback regulations and Stark laws, and discuss how marketing activities can trigger either or both.
CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements.
These activities must be properly documented.
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and typical mitigation steps to effective contamination control.
This webinar about risk-based design control reviews the FDA’s and ISO’s guidance and regulations and provides practical ways to implement a robust risk-based design control in your company. It shows you practical ways to simply work and hand and enough spend time on actual risk management and mitigation.
This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.
Attend this webinar to learn how to be fully compliant with the USDA Final Rule on Bioengineered Food Disclosure, disclosure requirements in product labeling; disclosure options available to food manufacturers and distributors; symbols to be used and graphic requirements; and the timelines for compliance.
This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
Promoting employees from within is not without its risk and if not handled properly can result in potential legal liability. This webinar will offer attendees an understanding of what should be accomplished when promoting current employees to management or supervisory positions.
Dietary Supplement companies must ensure that any product claims they make are “truthful and not misleading” under FDA and FTC regulations. To meet these standards, the FTC has stated that claims must be substantiated by “competent and reliable scientific evidence.” This course provides strategies to: 1) identify claims; 2) characterize/rank claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.
Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).
Attend this training to understand the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines. The training will also briefly take you through the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.
