Determining Excreted Drug Dangers under USP 800
Jim Mullowney
60 Min
Product Id: 706096
In December of this year, USP 800 will take effect. Each entity that handles Hazardous Drugs (HD’s) must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures overseeing entity compliance with USP 800 and other applicable laws. This course will show you how to determine which of the almost 300 HD’s you need to handle in the same manner in the pharmacy and as they are excreted by the patient. We will look at recommendations from the international Society of oncology pharmacy practitioners (ISOPP) on the list of drugs with excretion times as well as other sources.
Basics of Testing Associated with Sterilization Validation and Routine Processing
Gerry O Dell
60 Min
Product Id: 701330
This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.
Veterinary Pharmacy Law: New Regulatory Update
Bernadette Alisantosa
60 Min
Product Id: 705609
This webinar will cover the legal regulations for dispensing and record keeping of controlled substances. This training will discuss the new changes in food animal antimicrobial drugs from OTC to Rx. Compounding guidelines and legal ramifications of dispensing human drugs to animals will be discussed in detail. It will review new drug dosages forms and extra labels use and further it will review what is legal for technicians and what to do when handling medications.
Implementing a GxP Quality Management System
William D Fox
90 Min
Product Id: 706079
This 90-minute GxP Quality Management System webinar introduces you to the planning and implementation of a QMS using a pharmaceutical QMS as a working model and focuses on fundamental concepts of quality, managing quality, systems, processes, managing change and assessment tools.
Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
J. Jeff Schwegman
90 Min
Product Id: 702893
This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.
Onboarding in a GMP Environment: Best Practices for Foundational Employee Success
Michael Esposito
75 Min
Product Id: 705475
This onboarding course is geared toward the pharmaceutical industry, particularly for anyone who is responsible for managing or delivering training in a GMP environment, and HR employees who interact frequently with the GMP training organization to coordinate onboarding. The aim of the course is to provide practical information, which has already been used on the job effectively, and suggest similar actions that learners can apply to their job situations quickly.
Best Practices of Writing SOPs
Michael Esposito
90 Min
Product Id: 705614
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.
Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program
Todd Graham
60 Min
Product Id: 703066
This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
Sunil Gupta
90 Min
Product Id: 704302
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
Strategies to Mitigate Preclinical Safety Risks in Drug Discovery
Bryan Norman
90 Min
Product Id: 706071
This webinar will discuss current best practices in understanding, assessing and mitigating many preclinical safety concerns in drug discovery. It will highlight many of the primary factors impacting drug safety, such as drug properties, target and tissue specificity, metabolic profile and reactive metabolite formation. It will also demonstrate many modern preclinical mitigation strategies and techniques to improve the safety of potential drug candidates.
U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
Norma Skolnik
60 Min
Product Id: 704371
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection
Max Lazar
60 Min
Product Id: 705985
In this FDA inspection webinar attendees will learn the basic understanding of Active Pharmaceutical Ingredient Good Manufacturing Practices (ICH Q7) and the most important elements of API GMP to avoid serious deviations and failures during either a Pre-Approval or GMP Inspection.
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products
Angela Bazigos
90 Min
Product Id: 704529
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
Software Validation and its 11 Key Documents
John E Lincoln
90 Min
Product Id: 703097
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
Practical Implementation of Pharmaceutical Quality Risk Management (QRM)
Steven Laurenz
60 Min
Product Id: 706012
In this Pharmaceutical Quality Risk Management webinar attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, the level of risk based on severity, occurrence, detectability and how the QRM process is used to make decisions. Also attendees will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management risk tools and their application.
FDA Regulations and New Legislation for Marketing Cosmetics in the U.S
Norma Skolnik
60 Min
Product Id: 704317
The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.
505(b)(2) NDAs
Peggy Berry
60 Min
Product Id: 705930
In this webinar attendees will learn which products qualify for submissions under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) and the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer
Gregory Martin
90 Min
Product Id: 703644
This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.
CDISC Mapping 2: ODM, MindMaps and References
Sunil Gupta
90 Min
Product Id: 704208
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
Risk Based Monitoring for GCP Compliance
Laura Brown
60 Min
Product Id: 705052
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.