Webinars

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
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.
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.
US FDA Requirements for Medical Products Labeling / UDI

US FDA Requirements for Medical Products Labeling / UDI

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.
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.
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.
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.
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance

The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.
GMP Environmental Monitoring for Pharmaceutical Clean Rooms

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

The California Consumer Privacy Act (CCPA) was enacted into law on June 28, 2018 and became effective on January 1, 2020. CCPA provided a variety of consumer privacy rights and the obligations of business related to their storage and sale of personal information.

Voters in California voted to approve Proposition 24, a ballot measure, on November 3, 2020, which created the California Privacy Rights Act (CPRA). The purpose of CPRA was to modify and expand the requirements of the CCPA, thus amending the original act. CPRA is commonly referred to as “CCPA 2.0.”

CPRA ends the ban on providing the CCPA’s consumer privacy rights to a company’s employees. Under CPRA, all employers must respond to requests from employees to access or correct their personal data. Enforcement of CPRA will become effective in July 2023, enabling companies six months to ramp up their efforts to comply with it.

CPRA also extends new protections to consumers residing in California. Those organizations doing business with these consumers are subject, based on defined threshold of operation, to the compliance requirements.

How to Achieve Validation Requirements for a Clean Room Manufacturing Environment

How to Achieve Validation Requirements for a Clean Room Manufacturing Environment

Both the U.S. FDA and EU's MDR expect documented risk-based clean room manufacturing environment per ISO 14644-series, ISO 14698-series (and the old FED-STD 209E).
Optimizing Target Weights for Foods and Beverages

Optimizing Target Weights for Foods and Beverages

This training program will elaborate factors affecting the target weight decision and help determine the tolerable risks of under-filling and the costs of over-filling. Attendees will gain an understanding of process stability and process capability concepts and methods for process optimization.
US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes

US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes

The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).
Cybersecurity - The Latest US FDA  Requirements

Cybersecurity - The Latest US FDA Requirements

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 
Validation Statistics for Non-Statisticians

Validation Statistics for Non-Statisticians

In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the concept of process capability and using process capability to set acceptance criteria for validation.
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration. Does your DHF remediation process resemble the very mess that it is trying to resolve?
The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards. While it is retrospective in nature, it is the end result of a process that begins with planning and ends with Design Transfer and has the Device Master Record (DMR) as a deliverable.
Medical Device Cybersecurity Risk Management Training

Medical Device Cybersecurity Risk Management Training

This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
Risk Management for Medical Devices per ISO 14971 2019

Risk Management for Medical Devices per ISO 14971 2019

ISO 14971:2019 has introduced significant changes including benefit, reasonably foreseeable misuse and state of the art, as well as the management of risks associated with medical devices. It is important to be aware of these changes as technology continues to emerge.
How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity

How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

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