Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.

This FDA validation training will guide you through the validation planning which required meeting the US FDA & ISO 13485 Requirements. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. Also: The roles of different V&V protocols; How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budgets, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are considered.

This CAPA training will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. This presentation will begin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is “Corrective Action Preventive Action” otherwise referred to CAPA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/level will then ensue. Upon completion of risk part of the presentation we will define what a CAPA system would look like.

The presentation will focus on CAPA as it applies to risk mitigation. We will define what we mean by a CAPA system. We will further define the tools CAPA uses during implementation. Finally an overview of a CAPA system will be presented and a CAPA approach will be proposed. The approach will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. We will also review some of the benefits which may accrue by having a robust CAPA system in place.

This FDA GMP (Good Manufacturing Practice) inspection training will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.

This Cleaning validation training will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes. This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Recent FDA warning letters illustrate just how critical good cleaning practices are. Understanding and employing good cleaning practices are instrumental to improving cleaning consistency, quality and traceability. The FDA favors automated CIP systems since they reduce operator variability while enhancing consistency and reproducibility. Our research has indicated that in the last 5 years, cleaning citations were noted in 50% of warning FDA letters. Many cited contamination issues have an element of poor cleaning practices associated with them. Examples include “investigations…did not include an evaluation of the cleaning processes and procedures…to determine if equipment cleaning is effective in preventing cross contamination of the inactivated batches”, FDA Warning Letter, Jan 2008; "vaccine manufacturing plant in Pennsylvania, has been served with an FDA warning letter asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.” Jul-2006..

An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.

This Laboratory compliance training will help to understand and implement the new USP chapter.

This Medical device training will provide valuable assistance and guidance to device companies involved in labeling changes. FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information “must reveal risks of a different type or greater severity or frequency than previously included in submissions” and includes meta-analyses, the new regulation states.” FDA requires that drug, biologics, and medical device manufacturers obtain FDA approval of their warning labels before the drugs or devices are marketed and sold. Manufacturers generally must also obtain FDA approval before making changes to labeling information. However, in limited circumstances, companies can revise or supplement their warning labels prior to FDA approval (through changes being effected (CBE) supplements) to ensure consumers are immediately made aware of newly discovered risks.

The labeling regulations, which became effective in late September 2008, clarify that a manufacturer can make unilateral pre-FDA approved labeling changes “only to reflect newly acquired information” when there is “reasonable evidence of a causal association” between the drug or device and the risk. The final rule defines “newly acquired information” as “information not previously submitted to [the] FDA.” This includes “new analyses of previously submitted data,” such as adverse event reports, new clinical study information, and new analyses that “reveal risks of a different type or greater severity or frequency than previously included in submissions to [the] FDA. Under the final rule, however, a CBE supplement is available only if there is "sufficient evidence of a causal association" justifying the addition or strengthening of a contraindication, warning, precaution or adverse reaction. The FDA explains that the language "sufficient evidence of a causal association" refers to the standards for drugs and biologics set forth in §201.57(c)(6) and §201.57(c)(7).

This FDA compliance training will describe the essential requirements for producing sterile products in a practical, clear, concise manner that will facilitate its implementation.

This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.

This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address. The U.S. FDA’s Design Control requirements of the QS Regulation mandate the initiation and maintenance of a product Design History File for products to be marketed in the U.S. The European Union’s Medical Device Directive and a company’s Notified Body require a Technical Dossier or Technical File to show compliance to the Essential Requirements of the MDD and associated relavant standards for product to be CE-marked and marked in those countries (and others). Attendees will be helped to see how to understand the similarities and differences of these two complimentarty documents. Attendees will be further helped to comply with the respective requirements and develop compliant files to address either or both.

This Validation training will explain the intent and importance of process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This Process Validation training will detail the key qualification steps in process validation, the use of statistical methodology for sampling plans and acceptance criteria, how to handle deviations, elements of a good validation summary report. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This Pharmaceutical training will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices. The scope of the FDA guidance document on Out-Of-Specification results addresses analytical excursions, not microbiological excursions (Microbiological Data Deviations - MDD), although the approach for correcting them is the same: 1) Determine the root cause 2) Determine a corrective and/or preventative action and 3) Demonstrate that the corrective/preventative action was effective. Recent FDA warning letters cite microbiological excursions and many companies are unsure how to correct them since there are no definitive guidance’s. This webinar will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices.

This Quality management training will show you how to use methods you probably already have in place to create effective preventive action. Linking these on-going tools to your CAPA program will increase the benefit. Many organizations focus on improving root cause problem solving and tracking issues and corrective actions. That’s a good beginning to a CAPA program. But many organizations don’t effectively implement Preventive Action.

This ASTM E2500 training will review how these ASTM (American Society for Testing and Materials) and ICH (International Conference on Harmonization) approaches can simplify the qualification process. Regulatory groups have responded by providing guidance documents such as ICH Q9: “Quality Risk Management” which encourages a level of risk appropriate to safety and efficacy and provides a toolbox of risk management methods. ICH Q8: “Pharmaceutical Development” encourages the use of scientific methods to mitigate risk through concepts such as Design Space, Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Verification.

This pharmaceutical training provides a detail review and evaluation of Regulatory requirements on pharmaceutical packaging materials from US and EU. This pharmaceutical training provides a detail review and evaluation of the regulatory requirements for packaging operations including description, suitability, protection, safety, compatibility, performance, Quality Control, supplier, and stability.

This Validation training will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This GLP (Good Laboratory Practices) webinar presents a straightforward summarization of the roles and responsibilities of all the people that contribute to a GLP study.

This Contamination-Control training will provide valuable assistance to companies that need to validate their cleaning and disinfection programs.

This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.