Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

6 / Mar / 2023 - Monday

 

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

 

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.

4 / Apr / 2023 - Tuesday

* Per Attendee $249

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 704315

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

11 / Apr / 2023 - Tuesday

* 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

 

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.

19 / Apr / 2023 - Wednesday

* Per Attendee $199

 

Commissioning and Qualification Training Course

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706911

This online program offers an introduction to the international principles and regulations behind commissioning and installation qualification (IQ).

21 / Apr / 2023 - Friday

* Per Attendee $199

 

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.

2 / May / 2023 - Tuesday

* Per Attendee $229

 

Useful Statistical Methods for Defining Product and Process Specifications - Part I

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 706897

This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

3 / May / 2023 - Wednesday

* 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

 

Useful Statistical Methods for Defining Product and Process Specifications - Part II

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 706898

This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

19 / May / 2023 - Friday

* Per Attendee $199

 

GAMP Data Integrity 21 CFR Part 11 Training Course

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706912

This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

25 / May / 2023 - Thursday

* Per Attendee $199

 

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).

6 / Jun / 2023 - Tuesday

* Per Attendee $249

 

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.

9 / Jun / 2023 - Friday

* Per Attendee $229

 

Normality Testing: Applications and Issues

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 706899

This webinar discusses applications of normality testing and several issues that may arise when testing data for normality. Several methods for testing data for normality are presented. We discuss some of the common types of goodness-of-fit tests that may be used (e.g. Andersen-Darling, Kolmogorov Smirnoff, etc.). We also discuss common reasons that normality tests are rejected.

15 / Jun / 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

 

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

 

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

 

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