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.

31 / May / 2022 - Tuesday

* Per Attendee $249

 

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.

7 / Jun / 2022 - Tuesday

* Per Attendee $249

 

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.

15 / Jun / 2022 - Wednesday

* Per Attendee $229

 

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.

24 / Jun / 2022 - Friday

* Per Attendee $229

 

The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   120 Min

Product Id: 705582

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

5 / Jul / 2022 - Tuesday

* Per Attendee $249

 

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

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).

13 / Sep / 2022 - Tuesday

* Per Attendee $249

 

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

 

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706563

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Recording Available

* Per Attendee $299

 

FDA's Ambitious Regulation of Social Media

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

 

How to Use Quality Systems Inspection Technique (QSIT) to Your Advantage

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700788

This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is clearly of high importance.

Recording Available

* Per Attendee $299

 

Best Practices in Preparation for an FDA Computer System Audit

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706354

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.

Recording Available

* Per Attendee $299

 

Report Writing for Auditing Professionals

webinar-speaker   Phil Vassallo

webinar-time   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.

Recording Available

* Per Attendee $249

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Analytical Method Validation and Transfer

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706186

This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.

Recording Available

* Per Attendee $299

 

FDA Compliance and Enforcement Trends focused on Data Integrity

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706353

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

Recording Available

* Per Attendee $299

 

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

webinar-speaker   John E Lincoln

webinar-time   60 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

 

21 CFR Part 111 - Current FDA 483 Observations and Warning Letters Review

webinar-speaker   Andy Swenson

webinar-time   60 Min

Product Id: 706772

The FDA inspects facilities, online marketing collateral and physical products to determine compliance with the 21 CFR Part 111 dietary supplement regulations. It is very helpful to review their observations to infer what their priorities are and where industries and companies alike can improve.

Recording Available

* Per Attendee $299

 

 

 

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