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How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities
Carlos M Aquino
90 Min
Product Id: 704617
The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
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CGMP controlled Raw Materials
Charity Ogunsanya
90 Min
Product Id: 705148
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
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FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
Danielle DeLucy
60 Min
Product Id: 704659
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
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Process Validation Requirements for FDA's Quality System Regulation
Susanne Manz
90 Min
Product Id: 706753
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the validation essentials for medical device manufacturers. You will learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We will cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
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Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR
Susanne Manz
90 Min
Product Id: 706751
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices.
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Medical Device Software Development Under IEC 62304
Don Hurd
60 Min
Product Id: 706744
ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Not complying with the standard has shown to lead to longer regulatory review times and frequent rejections.
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How to Conduct Successful Supplier Audits
Danielle DeLucy
60 Min
Product Id: 704499
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
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Tests of Equivalence and Non-Inferiority
Elaine Eisenbeisz
90 Min
Product Id: 706743
Tests of superiority, using null hypothesis statistical testing (NHST) are the norm in most research settings. However, there are situations where superiority of a treatment to a control is not needed, and sometimes it is not ethical to do so. For example, a researcher may be interested not in superiority, but instead, would like to compare the efficacy of a newer drug with a working treatment (an active control). In this webinar, Elaine Eisenbeisz will introduce types of statistical tests that can demonstrate that two treatments are ‘similar’ to each other in terms of their clinical effectiveness.
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How to write SOP's that Avoid Human Error
Ginette M Collazo
90 Min
Product Id: 704418
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
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Root Cause Analysis - The Heart of Corrective Action
Betty Lane
75 Min
Product Id: 703391
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
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Report Writing for Auditing Professionals
Phil Vassallo
90 Min
Product Id: 703814
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.
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Human Error Investigations, Root Cause Determination and CAPA Effectiveness
Ginette M Collazo
90 Min
Product Id: 704314
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
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Handling OOS Test Results and Completing Robust Investigations
Danielle DeLucy
90 Min
Product Id: 704351
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
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Software Design Controls in Life Sciences Applications
Eric Henry
4 Hrs
Product Id: 706736
This webinar will discuss the latest global medical device design controls requirements for software in a medical device (SiMD) and software as a medical device (SaMD). Each requirement pulled from U.S. and global standards and guidance (e.g. IEC 62304, IEC 82304, IMDRF SaMD Guidance, AAMI TIR45) will be explored to fashion a complete picture of activities, document content, and dependencies across a variety of lifecycle development models. The session will also include special topics such as evolving cybersecurity requirements, the relationship of software design controls to non-medical device applications, and proposed regulatory frameworks for AI/ML systems.
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Best Practices for an Effective Cleaning Validation Program
Joy McElroy
60 Min
Product Id: 704329
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
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Risk Management Under ISO 14971
Don Hurd
60 Min
Product Id: 706732
ISO 14971:2019 is the definitive standard for risk management for medical devices and IVDs. The standard lays out a comprehensive approach to managing risks in the life sciences. The course will discuss practical approaches to complying with the standard.
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Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Joy McElroy
120 Min
Product Id: 704086
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
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Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
Laura Brown
60 Min
Product Id: 701947
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
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Mobile Apps as Medical Devices
John E Lincoln
60 Min
Product Id: 706721
The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority. What are these issues / software app claims, and how will this affect the medical device industry.
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Human Error Reduction in GMP Manufacturing
Ginette M Collazo
90 Min
Product Id: 704107
This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.