Speaker Profile

David R
David R Dills
Director of Regulatory Services , CROMSOURCE,

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.

He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.

Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.

David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.

He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Upcoming Webinars Recorded Webinars
  • 14
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends

CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

David R Dills David R Dills | Duration:60 Minutes | Price: $149.00 | View Details
  • 16
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

FDA Issues Final Rule on Symbols in Labeling

The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.

David R Dills David R Dills | Duration:60 Minutes | Price: $149.00 | View Details
  • 20
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

David R Dills David R Dills | Duration:60 Minutes | Price: $149.00 | View Details
  • 21
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Postmarketing Vigilance Reporting For Medical Device Manufacturers

Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.

David R Dills David R Dills | Duration:60 Minutes | Price: $149.00 | View Details
  • 23
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Conducting Successful Product Complaint Investigations

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

David R Dills David R Dills | Duration:90 Minutes | Price: $149.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

David R Dills David R Dills | Duration:3 Hours | Price: $299.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

David R Dills David R Dills | Duration:90 Minutes | Price: $149.00 | View Details
David R Dills

Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends

CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
David R Dills

Postmarketing Vigilance Reporting For Medical Device Manufacturers

Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
David R Dills

3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
David R Dills

FDA Issues Final Rule on Symbols in Labeling

The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
David R Dills

Conducting Successful Product Complaint Investigations

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
David R Dills

Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
David R Dills

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
David R Dills

Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends

CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
David R Dills

Postmarketing Vigilance Reporting For Medical Device Manufacturers

Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
David R Dills

3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 3 Hours | Price: $549.00 | View Details
David R Dills

FDA Issues Final Rule on Symbols in Labeling

The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
David R Dills

Conducting Successful Product Complaint Investigations

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
David R Dills

Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
David R Dills

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details