Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

webinar-speaker   Elaine Eisenbeisz

webinar-time   90 Min

Product Id: 706650

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

8 / Dec / 2021 - Wednesday

 

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.

11 / Jan / 2022 - 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).

12 / Jan / 2022 - 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.

12 / Jan / 2022 - Wednesday

* Per Attendee $249

 

Calculations for Process and Product Capability

webinar-speaker   Elaine Eisenbeisz

webinar-time   90 Min

Product Id: 706629

Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

12 / Jan / 2022 - Wednesday

* Per Attendee $199

 

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.

20 / Jan / 2022 - Thursday

* Per Attendee $199

 

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.

25 / Jan / 2022 - Tuesday

* Per Attendee $229

 

USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 706164

Attend this webinar to learn how to be fully compliant with the USDA Final Rule on Bioengineered Food Disclosure, disclosure requirements in product labeling; disclosure options available to food manufacturers and distributors; symbols to be used and graphic requirements; and the timelines for compliance.

26 / Jan / 2022 - Wednesday

* Per Attendee $229

 

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.

26 / Jan / 2022 - 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.

1 / Feb / 2022 - Tuesday

* Per Attendee $249

 

Establishing a Robust Supplier Management Program

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706055

This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.

2 / Feb / 2022 - Wednesday

* Per Attendee $249

 

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.

7 / Feb / 2022 - Monday

* Per Attendee $229

 

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.

8 / Feb / 2022 - 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.

9 / Feb / 2022 - Wednesday

* Per Attendee $199

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

15 / Feb / 2022 - Tuesday

* Per Attendee $249

 

Best Practices for Preparing for an FDA Inspection

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706774

Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

Recording Available

 

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 705164

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

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

 

Federal Oversight of Laboratory-Developed Tests in Limbo: What’s the Regulatory & Legislative Outlook for LDTs?

webinar-speaker   Dennis Weissman

webinar-time   60 Min

Product Id: 706769

This webinar will discuss the current status and outlook for federal oversight of Laboratory Developed Tests (LDTs) amid bureaucratic infighting during the COVID-19 pandemic regarding the authority of the Food & Drug Administration (FDA) to regulate LDTs.

Recording Available

 

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

 

 

 

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