Webinars

Inspection and Audit Readiness Training for Medical Device Manufacturers

Inspection and Audit Readiness Training for Medical Device Manufacturers

This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections.
ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course

This live, interactive training webinar will examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements as part of “Laboratory Controls” during each Phase and what laboratory testing may be optional until the ingredient moves to its next Phase. It will determine what options exist — even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. Within the past several years the FDA has also issued a significant number of Warning Letters pertaining to 21 CFR 211.84 which involve management of raw/in-coming materials and which correspond to various sections within ICH Q7A. Please plan to attend the upcoming 90-minute Compliance OnLine webinar to learn how to avoid receiving this common citation and maintaining compliance with ICH Q7A. Please plan to bring an interdisciplinary group to obtain the most from this webinar.
Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

The objective of this live, interactive training webinar is to explore the role of media fills in assuring that manufactured product will retain the sterility assurance level prescribed by GMPs. It will review the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The webinar will also discuss media failures and how to “work through” them. Because of the sensitivity and importance of media fills, this live, interactive training webinar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills, in particular.
Combination Product Device Supplier Management Training

Combination Product Device Supplier Management Training

The U.S. FDA continues to increase its requirements for tighter control and management of vendors / suppliers / outsourcing. Combination products doubles the problems. And Covid 19 has compounded supply chain issues.
Conducting Remote Medical Device QMS Audits Training

Conducting Remote Medical Device QMS Audits Training

Remote QMS-CGMP compliance inspections are here to stay. Add it to your toolbox for vendor and remote site audits, especially for low to moderate risk companies.
Medical Device Process Validation Training for Professionals

Medical Device Process Validation Training for Professionals

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
GMP Compliance for Quality Control and Contract Laboratories

GMP Compliance for Quality Control and Contract Laboratories

This webinar will cover the requirements for laboratory controls under US GMP regulations, such as those relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues.
US FDA Labeling Requirements for Medical Devices

US FDA Labeling Requirements for Medical Devices

The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.
Pharmaceutical Data Integrity

Pharmaceutical Data Integrity

Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
Trial Master File and Clinical Data Management Regulated by FDA

Trial Master File and Clinical Data Management Regulated by FDA

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
Medical Device Change(s) and the 510(k)

Medical Device Change(s) and the 510(k)

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.
FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.
Supervising a Human Error Free Environment: You can do a Lot More than you Think

Supervising a Human Error Free Environment: You can do a Lot More than you Think

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches near root causes and root causes for supervision related errors and will address the main five elements to assure an error-free environment.
Good Laboratory Practices by Using The Quality Management System (QMS)

Good Laboratory Practices by Using The Quality Management System (QMS)

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
Transfer of Analytical Methods according to USP <1224>

Transfer of Analytical Methods according to USP <1224>

In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
Validation Sampling Plans

Validation Sampling Plans

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance

Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
Assess Impact For Supplier Change Notices

Assess Impact For Supplier Change Notices

This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.

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