
Understanding and Preparing for FDA Pharmaceutical Inspections
Michael Ferrante
90 mins
Product Id: 706965
This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.

Analytical Method Development, and Method Transfer
John E Lincoln
90 mins
Product Id: 707009
The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.

Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Michael Esposito
90 Min
Product Id: 706104
Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of these problems.

Performing Effective Management Review of the Quality System
David L Chesney
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.

Annual Current Good Manufacturing Practices (cGMP) Training
Kelly Thomas
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.

FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance
Carolyn Troiano
90 Min
Product Id: 707010
This webinar will focus on the computer systems and data that are regulated by FDA. These systems will require validation and the data must be created and maintained with integrity. We’ll cover what is required for Computer System Validation (CSV) and we’ll discuss the new draft guidance from FDA on Computer Software Assurance (CSA). We’ll also cover 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures. Finally, we’ll discuss the “ALCOA+” requirements for data integrity.

Effective Systems for Change Control in the Pharmaceutical Industry
David L Chesney
90 mins
Product Id: 705002
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
Michael Esposito
90 Mins
Product Id: 706067
Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them.

Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validations
John E Lincoln
90 mins
Product Id: 707011
Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano
90 Mins
Product Id: 707014
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.

Drug, Device and Combination Product Development
John E Lincoln
90 Mins
Product Id: 707015
This webinar provides a basic overview of the stages of development and V&V of the basic categories of medical products, from R&D through Production, and the US FDA regulatory and documentation requirements at the various stages.

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Joy McElroy
90 mins
Product Id: 705929
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

Onboarding in a GMP Environment: Best Practices for Foundational Employee Success
Michael Esposito
75 Min
Product Id: 705475
Onboarding new employees in a pharmaceutical company, which is required by law to follow the regulations governing current Good Manufacturing Practices (cGMP), creates additional complexities besides the Human Resources element. As government regulatory agencies have expectations regarding the process of qualifying employees to perform their job duties, it is essential to become familiar with these expectations and the implications that they have for the company’s training plan. In addition, companies have been penalized for failure to follow established regulations, which can create issues that can impede production, damage a company’s reputation, or ultimately lead to recalling or discontinuing product. Still, the process is not straightforward, and questions inevitably arise regarding the application of the regulations. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.

Using a Learning Management System (LMS) to Develop Pharma Training Curricula
Michael Esposito
90 Min
Product Id: 707006
Learn how to use Learning Management Systems (LMS) to create effective pharma training curricula and ensure GMP compliance. This webinar delves into the unique challenges of creating intuitive job position curricula, overcoming LMS limitations, and meeting FDA requirements. Discover how to define true pharma curricula, collect job function details, manage complex training needs, and demonstrate compliance during audits. Ideal for professionals looking to optimize training in pharmaceutical environments.

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Roger Cowan
60 Min
Product Id: 703727
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Conducting Effective Quality Audits: Beyond Audit Checklists
Michael Ferrante
60 Min
Product Id: 703539
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Joy McElroy
120 Min
Product Id: 704531
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Installation and Qualification of the Packaging Lines
John E Lincoln
90 Min
Product Id: 706996
Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Roger Cowan
60 min
Product Id: 703476
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Preapproval Inspection and Submission to the FDA
John E Lincoln
90 Min
Product Id: 706998
This webinar is intended to provide guidance regarding the FDA program to approve an NDA or an ANDA or PMA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or Class III device are found adequate to ensure and preserve the drug's identity, strength, quality, and purity, or the device's safety and performance.