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Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products
Sara Zborovski
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.
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Best Practices for Cleaning and Material Handling in Sterile Compounding Facilities
Kate Douglass
60 Min
Product Id: 703807
This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.
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Canadian Advertising and Marketing of Pharmaceuticals, Medical Devices and Natural Health Products
Sara Zborovski
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.
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Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation
Jessica Czamanski
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.
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Maintaining a Validated State – PV, PM and Statistics Associated with Current Regulation
Jerry Dalfors
80 Min
Product Id: 703637
This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.
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Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?
Cheryl Wagoner
60 Min
Product Id: 703584
This FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.
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Is Device Registration and Listing Stressing You Out?
Cheryl Wagoner
60 Min
Product Id: 703571
This webinar will provide clarification on which medical device facility or establishment must register and list, how to register and list, and how to coordinate the payment process to accomplish the actual registration or device listing.
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Current Good Manufacturing Practices (cGMPs)
Philip Russ
120 Min
Product Id: 703558
This webinar will cover in detail the current Good Manufacturing Practices (cGMPs) regulations for pharmaceutical products. Attendees will learn how to comply with these FDA regulations and avoid pitfalls.
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Utilization of a Lifecycle Validation Approach via a Quality System to Reduce Costs and Increase Compliance
James Carron
90 Min
Product Id: 703412
This webinar will explain how to incorporate a quality system into the validation process to reduce cost and ensure compliance. It will cover the analysis, design and initiation phases, including full implementation of the incorporation.
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Updated EU filing and registration procedures (including the new variation rules coming in to force)
Robert J Russell
60 Min
Product Id: 701535
This EU filing and Registration webinar will discuss in brief all the new EU clinical directives, its Impact and how companies can effectively align their filing and registrations processes to effectively implement the requirements of the regulations.
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Quality System Development: Strength, Compliance and Efficiency through Value Stream Mapping
Philip Russ
60 Min
Product Id: 703490
This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.
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Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment
Jerry Dalfors
90 Min
Product Id: 703560
This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.
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FDA Regulation of Tobacco Products: The Deeming Regulation - Impact on E-Cigarettes
Azim Chowdhury
60 Min
Product Id: 703107
This webinar on tobacco regulations will discuss FDA regulatory requirements for tobacco products. It will prepare you for FDA’s Deeming Regulations for cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products.
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Steps to Design and Develop an Effective Closed Loop Change Control System
Michael Kagan
90 Min
Product Id: 703489
This webinar will discuss how to design an effective change control system – electronic as well as paper-based – with traceability and closed loop verification built into the process.
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Current Trends in FDA Inspections
Michael Ferrante
90 Min
Product Id: 703485
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.
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Supplier Qualification Audit, A Risk Based Approach
Yasamin Ameri
60 Min
Product Id: 703477
This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.
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Integrating Risk Management into the CAPA System
Edwin L Bills
90 Min
Product Id: 700525
This webinar will explain what FDA expects in incorporating risk in the CAPA process, what strategies can be used to assign resources to CAPA activities, and how to manage multi-level CAPA processes so that they will not run afoul of the FDA during inspections
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FDA Guidance: Medical Device Recalls
Angela Bazigos
90 Min
Product Id: 703473
This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.
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The 510(k) Process and Risk Management
Edwin L Bills
90 Min
Product Id: 701497
This 510(k) and risk management webinar will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate that product is safe.
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Responding to Unsolicited Requests for Off-Label Information
Mukesh Kumar
90 Min
Product Id: 703464
This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.