Product Id: 705400
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert
Karl M. Nobert
Product Id: 703313
This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.
Product Id: 704145
This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.
Product Id: 705412
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
Rachelle D Souza
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.
Rachelle D Souza
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.
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries
Rossano V Gerald
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.
Product Id: 705158
This course will review the basic requirements of pet food nutritional labeling, including the eight required items all pet food labels must have and the agencies that define and enforce the rules. The course will also cover frequently asked questions within the industry including guaranteed analysis and calculating calorie content. For pet food manufacturers wishing to ensure compliance to the latest nutritional labeling standard, this course offers an overview of the necessary elements to ensure compliance.
Product Id: 704378
This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.
Product Id: 704912
This webinar will explore the benefits of internet-based manuals/IFUs (instructions for use), as well as the products that are eligible to replace paper manuals with internet-based manuals, along with the compliance and business requirements for implementing eLabeling.
Lena Cordie Bancroft
Product Id: 704579
This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.
US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Robert J Russell
Product Id: 704587
This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
Product Id: 704530
The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.
Product Id: 703621
The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.
Robert J Russell
Product Id: 704356
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products
Product Id: 703830
The introduction of Vanessa’s Law in late 2014 has significantly changed the enforcement landscape, providing for the possibility of higher penalties than ever before in Canada. This training program will offer an overview of the new law and its potential impact on industry.
Product Id: 703760
This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.
Product Id: 703630
This webinar will highlight the distinctions between ISO 13485 and FDA’s QSR. It will further introduce attendees to key clauses and requirements pertaining to the two regulations and also detail internal audit requirements.
Product Id: 703658
This comprehensive study of the clinical supply process will address increasing efficiency in packaging and labeling. It will also detail compliance requirements that have to be met in the process. Participants will enjoy the opportunity to train under an industry expert and understand solutions for some of the most common challenges in the process.