Webinars

Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in Your Company Required by the EU MDR Regulation

Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in Your Company Required by the EU MDR Regulation

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One of those requirements is Article 15 Responsible Person for Regulatory Compliance. That role is a little bit similar to the role of the Qualified Person in the Pharma Industry but not the same and the new role is not the same as the Quality Representative for the quality management system. Your company must implement the new role in the organization structure and in the processes and take care of the qualification requirements.
The Role of Artificial Intelligence in Hospital Case Management

The Role of Artificial Intelligence in Hospital Case Management

Artificial intelligence (AI) has become a strategy to turn smart tasks into game-changing tools and technologies for healthcare providers. This has been documented in the processes of coding, diagnosing some diseases, and has assisted financial teams in identifying outcomes that would have all taken many hours by staff performing these tasks. Coupled with the right expertise, AI has been shown to be effective in case management departments, as well-especially with the utilization management process.
Consents and 42 CFR Part 2 - New Rules for Re-Release of Substance Use Disorder Information

Consents and 42 CFR Part 2 - New Rules for Re-Release of Substance Use Disorder Information

Managing release health information when it may involve substance use disorder treatment information requires good knowhow. This course focuses on the issues involved in doing so and how to handle it. It explains how HIPAA relates to information management and release and what processes are required for various releases of information under the HIPAA rules, including release according to individual access requests, and under consents and HIPAA authorizations.
Preclinical Development of Drugs with Special Emphasis on Biologicals

Preclinical Development of Drugs with Special Emphasis on Biologicals

Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.
HACCP - Conducting Effective Hazard Analysis

HACCP - Conducting Effective Hazard Analysis

HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP is aimed at prevention of contamination, instead of end-product evaluation.
Reviewing Drug Product Batch Records

Reviewing Drug Product Batch Records

Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
Corona Virus - 19:  New Risks with FDA Imports Logistics

Corona Virus - 19: New Risks with FDA Imports Logistics

Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to protect the health and well fare of your customer base, which actually is the entire U.S. population. In this webinar, you will mentally travel through your import process, how it will or can be derailed and identify issues you need to evaluate during the current interruption of your standard import business.
Batch Record Review and Product Release

Batch Record Review and Product Release

In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.
GXP: Quality Standards and Regulations for the Medical Device Field

GXP: Quality Standards and Regulations for the Medical Device Field

This webinar will discuss and define GXP’s, where the variable “x”, is Laboratory, Clinical, or Manufacturing. The webinar will focus on the requirements for each, and how they relate to the total product lifecycle, compliance, and inspections.
Implementing a Robust Data Integrity Program

Implementing a Robust Data Integrity Program

In this webinar, learn how to develop a data integrity governance program, and the principles for defining quality and data integrity processes and systems. It will examine common issues from FDA 483 observations and explain how to prevent them.
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

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.
Metrics for a Suitable and Effective Quality Management System

Metrics for a Suitable and Effective Quality Management System

Metrics and data are a key part of Management Review. Management needs to know how the quality system is performing, where the risks are, and where to invest precious dollars and resources for improvement. This course can help you determine what to measure, how to present information, and how to escalate issues for management review.
How to Create A PMS Plan and Report According to EU MDR 2017/745 Article 83-86?

How to Create A PMS Plan and Report According to EU MDR 2017/745 Article 83-86?

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the "Post-Market- Surveillance-Process" and the new requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according to ISO 13485:2016. The understanding of these changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.
Supplier Management with the new Medical Device Regulation EU MDR 745/2017

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.
Solving Statistical Mysteries - What Does FDA Want?

Solving Statistical Mysteries - What Does FDA Want?

This webinar provides some practical and useful answers to the question
What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?
FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

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.
Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies

Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies

This webinar provides guidance on how to justify sample sizes, and thereby indirectly provides guidance on how to choose sample sizes. Those justifications can then be documented in Protocols or regulatory submissions or can be given to regulatory auditors who may ask for them during onsite audits at your company. Thus, this webinar is designed to help you avoid regulatory delays in product approvals and to prevent an auditor from issuing you a nonconformity.
Metrology - Statistical Analysis of Measurement Uncertainty

Metrology - Statistical Analysis of Measurement Uncertainty

Attend this webinar to learn about the fundamental vocabulary and concepts related to metrology including accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation including Gage R&R, Gage Correlation, Gage Linearity, and Gage Bias described and explained. You will learn how to combine all relevant uncertainty information into an "Uncertainty Budget" to determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications").
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.
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

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.

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