Charles DeLeon

Growing a Compliance Program in Government Contracting

The Federal Government is a huge bureaucratic-type of organization, with a lot of moving parts, that serve different functions spread out around the world. Within this large structure, it has complex processes built upon numerous requirements that companies seeking to contract with the US Government must follow. To ensure that they are complying with the various contractual, regulatory and statutory requirements expected from government contractors, most, if not all large and mid-size government contractors devote personnel and resources to perform compliance functions to reduce the exposure to penalties and other consequences.

Michael Brodsky

The Enigma of a Healthy Diet

The difficulty of developing and validating reliable analytical approaches will also be discussed. There is need for reliable data to address public health issues associated with produce. There are no harmonized criteria or method classification system to assist laboratories in choosing appropriate methods.

Heath Rushing

Quality by Design: Establishing a Systematic Approach to Pharmaceutical Development

This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

John N. Zorich

Statistical Analysis of Gages (Metrology)

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.

Albert A. Ghignone

21CFR Part 58 - The Good Laboratory Practices (GLP) Regulation

FDA regulates the nonclinical safety testing of Drugs, Biologics and Medical Devices under a regulation called The Good Laboratory Practices (GLP)regulation. This webinar will address the reasoning for and the requirements of the GLP regulation. Every section of the GLP (Subparts A - Subpart K) will be addressed. FDA's "umbrella" approach to the GLP will also be discuss and FDA interpretations of the GLP reviewed.

David R. Dills

FDA's Update on Medical Device 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.

Albert A. Ghignone

The 510(k) Program: Substantial Equivalence In Premarket Notifications (510(k))

FDA developed this document to provide guidance about current FDA review practices for premarket notifications – 510(k) submissions. FDA's intent is to identify, explain and clarify each of the critical decision points in the 510(k) decision making process FDA uses to determine substantial equivalence.

Russ Gray

Part 4 Implementation for Combination Products

Information provided will allow an attendee to determine if their company is distributing combinations products, to understand the various forms of combination products, as defined by the FDA, to understand the Part 4 regulations, and to understand the manufacturer’s options with respect to complying with the Part 4 regulations. This topic will also briefly cover industry best practices in transitioning to full Part 4 regulatory compliance.

Lawrence F Muscarella  PhD

Five Hot Topics in Infection Control and Gastrointestinal Endoscopy

This lecture provides important background information about several dilemmas that infection control staffers face each day. It is important to understand this background information so that educated, evidence-based decisions can be made to reduce costs without compromising patient safety. Failure to properly clean and disinfect GI endoscopes and their accessories has been directly linked to disease transmission, with associated patient morbidity and mortality, increasing a GI endoscopy suite's legal exposure.

Honorio Silva

Core Competencies for Pharmaceutical Physicians and Other Professionals Involved in Medicines Development

For some time now, the biopharmaceutical industry has been the key link between basic biomedical discovery and the emergence of novel medicines that prolong or improve life. However, the overall success in medicines development is low. On the other hand, there is a perceived mismatch between the profile of the graduates from academic programs in biomedical professions and the changing needs of the various health related systems around the world.

Susan Rocca

Differences Between API and Product Manufacturing - Points to Consider when Auditing

The development of the modern pharmaceutical industry through the 20th and 21st centuries has been accompanied, or in some case followed, by the development of controlling legislation and guidelines. The focus of this control has historically been greatest for pharmaceutical dosage forms. This is perhaps not unreasonable, these products are closest to the patient and are historically where most, and the most significant, problems have occurred.

Albert A. Ghignone

The FDA Drug Development Process

This webinar provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.

David Nettleton

Excel Spreadsheet Validation To Eliminate 483s

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Albert A. Ghignone

Drug Approval: The FDA IND-NDA System

This webinar presents an overview of the entire FDA Drug Approval Process. The webinar addresses FDA requirements from discovery to USA marketplace. The webinar begins by developing a molecule, testing it, going through the IND process, human clinical testing and then the NDA process.

David Nettleton

Efficient Computer System Validation - 10 Easy Steps

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.

John E Lincoln

Product Hazard Analysis and Risk Management Under ISO 14971 and FDA, ICH Q9

This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document".

David R. Dills

Webinar on Medical Device Tracking

The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so.

Heath Rushing

Using Design of Experiments (DOE)for Product-Process Development

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.

John N. Zorich

Confidence-Reliability Calculations and Statistically Valid Sample Sizes

Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement data that cannot be transformed into normality.

Anna Longwell

Customer Interactions: Law, Policies, Ethics

The proliferation of legal requirements (law and regulation) governing the financial relationships between medical product companies and the doctors who order their products has led to what can only be described as a tangled mess. Many device companies have had to add personnel, or employ expensive consultants in order to have a hope of complying.

Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Lawrence F Muscarella  PhD

Solutions for Improving Infection Prevention in the Endoscopy Suite

This lecture focuses on the contribution of quality to patient safety and the practice of cost-effective medicine. Failure to properly clean and disinfect GI endoscopes and their accessories has been directly linked to disease transmission, with associated patient morbidity and mortality, increasing a GI endoscopy suite's legal exposure.

John E Lincoln

The Master Validation Plan - The Unwritten 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 company-wide V&V planning.

Robert J. Russell

Policies and Procedures for European Union Filings

This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

David R. Dills

FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List

Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.

Dr. Ludwig Huber

FDA Compliant HPLC Qualification and Performance Testing

High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.

Steven S Kuwahara

GMP Perspectives on Working with Contracting Laboratories

When working with contract testing laboratories, clients must remember that the responsibility for compliance with the GMP or the GLP ultimately lies with the product sponsor. Even if the contract assignes the responsibility to the contract laboratory, the responsibility for assuring compliance lies with the client. Neither can the contract laboratory assume that the client has complied with their responsibilities.

Steven S Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

John E Lincoln

Compiling the Design History File, and Technical File, Design Dossier

This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.

David Nettleton

GxP Computer System Validation, The investigator's Point of View

The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors.

Anna Longwell

Software and FDA

This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device

Robert J. Russell

The European Clinical Trial Directive (EUCTD)

The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.

Lawrence F Muscarella  PhD

Risk of Transmission of Carbapenem-Resistant Enterobacteriaceae (CRE) and Related 'Superbugs' during Gastrointestinal (GI) Endoscopy

This lecture focuses on the recent emergence of the superbug carbapenem-resistant Enterobacteriaceae (CRE). The details of a recent outbreak of CRE following GI endoscopy performed at a hospital in Illinois in 2013, with associated morbidity and mortality, is discussed. Failure to properly clean and disinfect GI endoscopes and their accessories has been directly linked to superbug transmissions, increasing a GI endoscopy suite's legal exposure. The history of transmission of infectious pathogens before and since CRE's emergence in 2001 is discussed.

Thomas E. Colonna

Introduction to FDA Regulation of In Vitro Diagnostics

In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.

Dan OLeary

Statistical Concepts of Process Validation

The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".

John E Lincoln

Change Control - Key to Successful cGMP Compliance

There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.

David R. Dills

How to Manage a Medical Device Recall Efficiently and Effectively

This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.

Melinda Allen

Foreign Material Control

Establishing HACCP, Preventative and Corrective Maintenance, GMPs and Pest Control programs will reduce foreign material contamination incidences and ensure safe, wholesome, unadulterated products for consumers.

Robert J. Russell

EU Pharmacovigilance Directive and Regulations

New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU.

Thomas E. Colonna

Introduction to Biomedical Software Regulation

The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).

Robert Kunka

Developing an Efficient Relationship with FDA

Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.

John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Dan OLeary

Device Corrections and Removals

When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?

Steven S Kuwahara

GMP Expectations for Products Used in Early Phase IND Studie

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

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