Webinars

Managing Non-conforming Material and Failure Investigations

Managing Non-conforming Material and Failure Investigations

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL

Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
Specification and OOS for Pharma, Biopharma and Combination Products

Specification and OOS for Pharma, Biopharma and Combination Products

This webinar will provide an overview of setting and maintaining specifications for Pharmaceutical and Biotechnology derived drug products throughout its shelf-life.
Onboarding in a GMP Environment: Best Practices for Foundational Employee Success

Onboarding in a GMP Environment: Best Practices for Foundational Employee Success

This onboarding course is geared toward the pharmaceutical industry, particularly for anyone who is responsible for managing or delivering training in a GMP environment, and HR employees who interact frequently with the GMP training organization to coordinate onboarding. The aim of the course is to provide practical information, which has already been used on the job effectively, and suggest similar actions that learners can apply to their job situations quickly.
In-House or Out House, A Corporate Dilemma

In-House or Out House, A Corporate Dilemma

This session will address factors that food companies need to consider before making decisions on outsourcing analytical food testing or retaining an in-house laboratory and the pros and cons of each approach.
Quality Management System - Structure and Development

Quality Management System - Structure and Development

This webinar will help you to develop a Quality Management System (QMS) for Medical Device Companies. An effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed. More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.
The PSMF- Accountability, Inspection Preparation and Business Analytics

The PSMF- Accountability, Inspection Preparation and Business Analytics

This webinar will discuss the structure of the PSMF as per EU Directive 2010/84/EU and how adopting this document in the US will provide a transparent process for Accountability, Inspection Preparation and Business Analytics.
Analytical Instrument and Equipment Qualification

Analytical Instrument and Equipment Qualification

This 90-minute webinar will help you gain an understanding of the regulatory background and provide complete guidance starting from the planning and writing requirement specifications to vendor evaluation, installation and operational qualification and continued testing while in routine use. The webinar also covers the instrument qualification and system validation processes.
Webinar On FDA Inspection Readiness

Webinar On FDA Inspection Readiness

This FDA inspection webinar will show you what it means to be “Inspection Ready” and how a Quality System in place at your company will ensure ongoing quality measures to be ready at any time for an audit, review by a Sponsor or any regulatory agency inspection.
Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 and Beyond

Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 and Beyond

In this prescription drug pricing webinar attendees will the key components of the trump administration on drug pricing plan, elements of the white house drug pricing blueprint and the federal policy outlook for U.S. drug pricing in 2019 and beyond.
Reducing Variability in Cell-Based Methods Using Process Controls

Reducing Variability in Cell-Based Methods Using Process Controls

This webinar will provide a general overview of the cell-based methods using process controls as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures.
Utilization and Denial Management for the Hospital Case Manager and Leader:  Medical Necessity in the World Busy Case Managers and AI

Utilization and Denial Management for the Hospital Case Manager and Leader: Medical Necessity in the World Busy Case Managers and AI

This Utilization and Denial Management webinar will assist the case management department leader and RN case manager in understanding the role of utilization management in a busy case management department. Determining the optimal model for ensuring the best approach to making sure that all cases are billed appropriately and timely is essential. This webinar will discuss two models, as well as the new concept of artificial intelligence that can be utilized as an adjunct to the medical necessity process.
Establishing a Medical Device Security Program

Establishing a Medical Device Security Program

In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment. It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.
Allergen Cleaning and Risk Mitigation for FSMA

Allergen Cleaning and Risk Mitigation for FSMA

In this food safety webinar attendees will learn how to set up a robust allergen control plan with latest approaches for cleaning, validation, monitoring and preventative controls required under FSMA (Food Safety Modernization Act). Also attendees will learn insights for testing, laboratory review and cleaning practices to improve or review their allergen management program.
Achieving Success and Compliance in the Supply Chain

Achieving Success and Compliance in the Supply Chain

This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
Facilities Management Training Course

Facilities Management Training Course

The purpose of this facilities management training course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.
Integrating Production Equipment, Processes, Systems and Procedures

Integrating Production Equipment, Processes, Systems and Procedures

Both the U.S. FDA and EU's MDR expect documented risk-based equipment, process,systems and procedures development, integration and maintenance.
FDA Regulation of Artificial Intelligence & Machine Learning

FDA Regulation of Artificial Intelligence & Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.
Lean Manufacturing For U.S. FDA-Regulated Industries

Lean Manufacturing For U.S. FDA-Regulated Industries

New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.
Medical Products Manufacturing Operations, Regulations and Controls

Medical Products Manufacturing Operations, Regulations and Controls

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

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