Process Validation - Current Industry Practices and FDA Guidance Document Review
John R Godshalk
60 Min
Product Id: 705316
This webinar will cover basics of process validation along with current industry practices. It will also discuss recent FDA draft guidance document and the importance of good process validation.
Drug Pharmacy Compounding
Rachelle D Souza
60 Min
Product Id: 704907
This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
Pharmaceutical Packaging - Regulations and Testing Standards
Thomas Feinberg
90 Min
Product Id: 705305
This webinar will present the current state of US and EU (pre-Brexit) regulatory policy with some insights into the CFDA (China) related to pharmaceutical packaging and testing. A unified risk assessment strategy will be presented to guide laboratory and eventual regulatory reporting activities.
ICH Q11 - API Manufacturing
Peggy Berry
90 Min
Product Id: 705303
The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical implementation of those requirements.
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
John R Godshalk
60 Min
Product Id: 704841
This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.
Vendor Qualification for Quality Services
Todd Graham
60 Min
Product Id: 705285
This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.
FDA vs Health Canada
Rachelle D Souza
60 Min
Product Id: 704862
This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.
How to Transfer Non-Compendial and Developed QC Procedures - ICH and USP Guidelines
Barbara Berglund
90 Min
Product Id: 701845
This webinar will explain ICH and USP guidelines for validation and how to apply ICH guidelines for method transfer and how to establish boundaries.
Creating and Maintaining an Effective and Efficient Technical Training Programs
Ginette M Collazo
90 Min
Product Id: 704373
This training program will analyze key elements of training programs in regulated environment. It will also list key performance indicators related to training and offer best practices for developing technical training programs to improve their effectiveness.
Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach
Saeed Qureshi
120 Min
Product Id: 705256
This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.
TSCA Awareness Program for 2017
Joe Keenan
90 Min
Product Id: 705251
This training program will clearly define all requirements of the Toxic Substance Control Act (TSCA). It will discuss best practices for developing TSCA written plans and TSCA training plans, as well as breakdown all components of the TSCA.
Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies
Peggy Berry
90 Min
Product Id: 705255
This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing
Henry Urbach
90 Min
Product Id: 703474
This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.
Preparing Stability Protocols for Development and Commercial Products
Peggy Berry
90 Min
Product Id: 704459
This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.
How to Design and Implement a Dynamic Control Plan
William Levinson
90 Min
Product Id: 705171
Learn how the FMEA and control plan can be combined to create a dynamic control plan, a living document that helps to drive continual improvement.
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries
Rossano V Gerald
60 Min
Product Id: 705186
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
GMP Training Practices to ensure Regulatory Compliance
Henry Urbach
90 Min
Product Id: 705077
By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.
How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"
Carlos M Aquino
60 Min
Product Id: 705163
The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Joy McElroy
90 Min
Product Id: 704306
This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.
3-Hour Virtual Training: Lean Leadership, Quality and the Customer
Charles H Paul
180 Min
Product Id: 705109
Lean is not a quick fix for doing more with less and doing it in half the time – it is not something you undertake to realize short-term improvements – it is on the other hand, a new way of thinking about your business and a new way of executing business activities. This virtual training and the others in the series will lead you through the journey of lean from its inception through complete implementation.