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Webinars

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.
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.
Clinical Study Risk Management including Compliance During The COVID-19

Clinical Study Risk Management including Compliance During The COVID-19

Attend this webinar to understand the key requirements for risk management of clinical trials to comply with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.
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.
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.
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.
Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry

Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry

Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
Sample Re-Analysis: Considerations for Incurred, Analytical and Pre-analytical requirements

Sample Re-Analysis: Considerations for Incurred, Analytical and Pre-analytical requirements

Sample re-analysis can be a quagmire of decision and indecision. Incurred sample re-analysis is required in regulated labs, but resolution of disparate results can be another difficult area. Pre-analytical issues- including mislabeling or absent sample as well as analytical issues add a measure of difficulty as well. This presentation will address these issues and help formulate acceptable resolutions.
FDA Compliance for Mobile Applications

FDA Compliance for Mobile Applications

Attend this webinar to understand the FDA guidance for mobile applications. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation. We will pay special attention on the issue of validation of mobile applications.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
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.
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.

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