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

webinar-speaker   David Nettleton

webinar-time   75 Min

Product Id: 701582

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

22 / Feb / 2023 - Wednesday

* Per Attendee $229

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time   90 Min

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

14 / Mar / 2023 - Tuesday

* Per Attendee $249

 

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706882

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.

30 / Mar / 2023 - Thursday

* Per Attendee $199

 

USP <61>/<62> Microbiological Enumeration and Examination of Non-Sterile Products – Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706883

The objective of this live, interactive webinar is to explore the changes to these historic USP test methods, compare them to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.

13 / Apr / 2023 - Thursday

* Per Attendee $199

 

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

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706884

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”.

11 / May / 2023 - Thursday

* Per Attendee $199

 

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706561

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

Recording Available

* Per Attendee $299

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

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.

Recording Available

* Per Attendee $249

 

Cybersecurity and US FDA Requirements

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706716

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.

Recording Available

* Per Attendee $299

 

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701432

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.

Recording Available

* Per Attendee $299

 

Assess Impact For Supplier Change Notices

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706344

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.

Recording Available

* Per Attendee $299

 

Impact Assessment for Change Control

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706337

Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.

Recording Available

* Per Attendee $299

 

How to Prepare for and Conduct a Regulatory Audit

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706849

In this Regulatory Audit training participants will gain an understanding of how to prepare for and audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the Covid-19 Pandemic.

Recording Available

* Per Attendee $299

 

FDA Ambitious Regulation of Social Media and Corporate Responsibility

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Recording Available

* Per Attendee $279

 

Major CGMP Issues - US FDA Concerns in 2022

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702185

This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.

Recording Available

* Per Attendee $299

 

Data Integrity Compliance for Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706352

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to Data Integrity, and how to improve your practices to meet compliance requirements.

Recording Available

* Per Attendee $299

 

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 705433

The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

Recording Available

* Per Attendee $299

 

Performing Effective Management Review of the Quality System

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 704933

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706348

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.

Recording Available

* Per Attendee $299

 

The FDA Inspection Process: From SOP to 483

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700269

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

Recording Available

* Per Attendee $299

 

21 CFR Part 111 - Specification Requirements

webinar-speaker   Andy Swenson

webinar-time   60 Min

Product Id: 706794

The 21 CFR Part 111 dietary supplement regulations require six categories of specifications before established before manufacturing product or releasing a batch into distribution. This course will review the six categories and their regulatory requirements while translating those requirements into a workable document.

Recording Available

 

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