WEBINARS

 

FDA Packaging and Labeling Regulatory Compliance Training - Live Webinars, Recordings & CDs

Implementing a Bullet Proof Quality System for FDA Audit Success

webinar-speaker   Meena Chettiar

webinar-time   60 Min

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.

Recording Available

 

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

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.

Recording Available

* Per Attendee $349

 

FDA Regulations for Marketing OTC Drugs and New Legislation

webinar-speaker   Norma Skolnik

webinar-time   60 Min

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.

Recording Available

* Per Attendee $299

 

Classifying Medical Devices - US and EU

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 705045

The Medical Device Classification webinar explains the classification system in US and the EU.

Recording Available

* Per Attendee $229

 

Risk Based Approach in cGMP - Quality Risk Management (QRM)

webinar-speaker   Shana Dressel

webinar-time   60 Min

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.

Recording Available

 

Drug Pharmacy Compounding

webinar-speaker   Rachelle D Souza

webinar-time   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.

Recording Available

* Per Attendee $249

 

FDA vs Health Canada

webinar-speaker   Rachelle D Souza

webinar-time   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.

Recording Available

 

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

webinar-speaker   Rossano V Gerald

webinar-time   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.

Recording Available

 

Pet Food Nutrition Label Requirements

webinar-speaker   Derrick Swint

webinar-time   90 Min

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.

Recording Available

* Per Attendee $229

 

Packaging and Labeling for Commercial and Clinical Products

webinar-speaker   Peggy Berry

webinar-time   90 Min

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.

Recording Available

* Per Attendee $279

 

eLabeling for Medical Devices: Valuable but not easy

webinar-speaker   Daphne Walmer

webinar-time   90 Min

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.

Recording Available

* Per Attendee $249

 

Preparing for a UDI Implementation

webinar-speaker   Lena Cordie Bancroft

webinar-time   90 Min

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.

Recording Available

 

US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

webinar-speaker   Robert J Russell

webinar-time   90 Min

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.

Recording Available

* Per Attendee $229

 

4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

webinar-speaker   Norma Skolnik

webinar-time   4 hrs

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.

Recording Available

 

3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections

webinar-speaker   Mukesh Kumar

webinar-time   60 Min

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.

Recording Available

* Per Attendee $229

 

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   3 hrs

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.

Recording Available

* Per Attendee $429

 

Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products

webinar-speaker   Sara Zborovski

webinar-time   60 Min

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.

Recording Available

* Per Attendee $229

 

Canadian Advertising and Marketing of Pharmaceuticals, Medical Devices and Natural Health Products

webinar-speaker   Sara Zborovski

webinar-time   60 Min

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.

Recording Available

* Per Attendee $229

 

Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

webinar-speaker   Jessica Czamanski

webinar-time   90 Min

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.

Recording Available

* Per Attendee $229

 

Packaging and Labeling of Clinical Supplies

webinar-speaker   Donald Levine

webinar-time   90 Min

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.

Recording Available

* Per Attendee $229

 

 

 

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