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.

13 / Jul / 2021 - Tuesday

* Per Attendee $249

 

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700986

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

13 / Jul / 2021 - Tuesday

* Per Attendee $199

 

Mobile Apps as Medical Devices

webinar-speaker   John E Lincoln

webinar-time   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.

14 / Jul / 2021 - Wednesday

* Per Attendee $199

 

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705583

In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

19 / Jul / 2021 - Monday

* Per Attendee $229

 

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

webinar-speaker   Laura Brown

webinar-time   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.

23 / Jul / 2021 - Friday

* Per Attendee $199

 

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704086

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

26 / Jul / 2021 - Monday

* Per Attendee $299

 

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 700817

This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.

28 / Jul / 2021 - Wednesday

* 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.

28 / Jul / 2021 - Wednesday

* 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.

4 / Aug / 2021 - Wednesday

* Per Attendee $249

 

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

webinar-speaker   Ginette M Collazo

webinar-time   60 Min

Product Id: 704210

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

10 / Aug / 2021 - Tuesday

* Per Attendee $229

 

21 CFR Part 11 and QMS Software Risk-Based Implementation

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 706363

CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.

11 / Aug / 2021 - Wednesday

* Per Attendee $199

 

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.

17 / Aug / 2021 - Tuesday

* Per Attendee $229

 

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).

18 / Aug / 2021 - Wednesday

* 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.

1 / Sep / 2021 - 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.

1 / Sep / 2021 - Wednesday

* Per Attendee $229

 

Writing and Revising SOPs for Increased Operational Efficiency

webinar-speaker   Rob MacCuspie

webinar-time   60 Min

Product Id: 706214

This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.

Recording Available

* Per Attendee $299

 

Validation Master Plan - The Unwritten Requirements

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 705877

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Recording Available

* Per Attendee $299

 

Human Error Reduction in GMP Manufacturing

webinar-speaker   Ginette M Collazo

webinar-time   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.

Recording Available

* Per Attendee $299

 

Cybersecurity and US FDA Requirements

webinar-speaker   John E Lincoln

webinar-time   60 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

 

The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 701568

This course provides 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

 

 

 

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