Product Approval, Promotions & post marketing surveillance for Medical Device Companies - Best Selling Package Webinar

ComplianceOnline has created these courses individually through world renowned experts and combined them together to create a comprehensive training resource for companies to train their employees. You can store it as a library material and train all your employees in these compliance issues to get them ready to face any kind of compliance challenge and overcome it through expert advice and best practices.

Do not delay any more. Hurry ! Get the whole set at 55% flat discount.

All Modules:

Module 1: Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance
Module 2: The 21 Elements of a 510(k)
Module 3: FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
Module 4: Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes
Module 5: FDA's Ambitious Regulation of Social Media

Module 1 : Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance - (Last Recorded Date: Nov-2015)

Areas Covered in the Webinar:

• Describe the primary benefits of implementing and maintaining effective post market surveillance.
• Review the requirements of post market surveillance.
• Introduce a methodology for evaluating existing post market surveillance processes.
• Outline implementation of an effective post market surveillance process.
• Elements of an effective post market surveillance process.

Instructor Profile:

Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Module 2 : The 21 Elements of a 510(k) - (Last Recorded Date: Dec-2016)

Areas Covered in the Webinar:

• Current Requirements of the FDA for a 510(k) submission
• Expected Sources of Information for Evaluation and Inclusion
• The 3 Types of 510(k) Submissions, and Their Uses
• Step-by-step analysis of the 21 Elements
• Changes to a Device after FDA Clearance
• Expected Submission Sequence of Events

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

Module 3 : FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes - (Last Recorded Date: Aug-2013)

Areas Covered in the Webinar:

• Prescription Device Labeling.
• Misbranding, False Or Misleading Labeling.
• Approval.
• Issuance.
• Label Integrity.
• Label Inspection.
• Contractor-Produced Labels As A Linkage With Purchasing Controls.
• Retention.
• When a labeling change requires a new submission.

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

Module 4 : Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes - (Last Recorded Date: Nov-2017)

Areas Covered in the Webinar:

• New approach directives & background
• IVD, MDD & Active Implantable Directive
• Impact of significant recent & proposed changes
• Competent Authorities & Notified Bodies
• Medical Device Directive vs. Regulation vs. ISO 13485
• Device classification
• Routes to CE marking under various MDD annexes
• Technical files vs. Guidance Documents
• Essential requirements
• Significant Changes Coming

Instructor Profile:

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. RAB Accredited Lead Auditor Course Certificate1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

Module 5 : FDA's Ambitious Regulation of Social Media - (Last Recorded Date: Aug-2017)

Areas Covered in the Webinar:

• FDA labeling vis-à-vis promotion and advertising via social media
• Direct to consumer marketing issues
• Fair and balanced information considerations
• Context of messaging and target population
• Exemptions for social media use
• Management roles and responsibilities

Instructor Profile:

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. Mr. Uldriks understands how FDA thinks, how it operates, and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Follow us :