The FDA Inspection Process: From SOP to 483
Jeff Kasoff
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.
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano
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.
Best Practices in Preparation for an FDA Computer System Audit
Carolyn Troiano
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.
How to Prepare a Standard Operating Procedure (SOP)?
Dr. Afsaneh Motamed Khorasani
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.
FDA Compliance and Enforcement Trends focused on Data Integrity
Carolyn Troiano
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.
21 CFR Part 111 - Current FDA 483 Observations and Warning Letters Review
Andy Swenson
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.
Good Documentation Guideline (Chapter <1029> USP)
Dr. Afsaneh Motamed Khorasani
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.
21 CFR Part 11 and QMS Software Risk-Based Implementation
John E Lincoln
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.
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
Ginette M Collazo
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.
Establishing a Robust Supplier Management Program
Kelly Thomas
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.
Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP
John E Lincoln
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.
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure
Kelly Thomas
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.
Calculations for Process and Product Capability
Elaine Eisenbeisz
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).
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Dr. Afsaneh Motamed Khorasani
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.
How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances
Carlos M Aquino
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.
Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
Elaine Eisenbeisz
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.
Validation Master Plan - The Unwritten Requirements
John E Lincoln
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.
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
Charity Ogunsanya
90 Min
Product Id: 703875
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
Implementing a Robust and Compliant Change Control Program
Kelly Thomas
90 Min
Product Id: 705909
This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program; as well as, discuss the elements regarding successful management an effective Change Control system.
How to Conduct a Human Factors / Usability Validation
Jose Mora
60 Min
Product Id: 706764
In this webinar, you will learn why the FDA requires several validation participants from each “distinct user population”. Learn why the FDA requires many validation participants from each "different user demographic" in this webinar. We'll go over how to determine which tests to run and which studies to finish before the actual validation test.