Current FDA Compliance Trends - Device And Drug
Frank Pokrop has worked in the medical device arena for more than 20 years and he is employed at Sotera Wireless in San Diego as the Senior Director for Regulatory Affairs and Quality Assurance. His prior experience covers manufacturing quality assurance for large and small volume parenteral drugs.
Frank’s responsibilities cover management of staff and budget, global submissions, worldwide regulatory intelligence, project management, auditing and compliance, recall management, and training. In one role with a Fortune 100 company, he was the formal liaison to the FDA and worldwide health agencies representing drugs, devices, IVD’s and infant formula and in this role, he reported to a corporate officer.
For eight years he managed a worldwide auditing program covering 48 global sites and at a different company, he was an independent reviewer of corporate audits.
A long-standing supporter of training and personal development, Frank has spent a considerable amount of time in volunteer positions including: (1) He was a member of MD&DI's Editorial Advisory Board from 2006 - 2016, (2) He has been an officer and volunteer with the San Diego Regulatory Affairs Network (SDRAN) since 2010 and was president in 2017, (3) He has been a member of the “B” IRB at UCSD since 2015, and, (4) He has taught an introductory course on medical devices at UCSD since 2017. He is a frequent contributor and speaker with ASQ and RAPS both locally and at national meetings. While at SDRAN he organized seminars on jobs and careers and routinely assisted members with resumes, cover letters and finding employment.
His certifications include: RAC, CSQE, CISA and CPGP.
Inspections and compliance are ever-present topics in FDA’s regulated world. The webinar will identify trends for drugs and devices as well as inspectional practices and emerging issues affecting inspectional outcomes. The speaker will cover statistics along with technical issues and practices and present CFR citations covering the last 5-10 years. Comparisons of trends and practices will be made in relation to discussions of personnel practices and capital investment, particularly on the drug side.
The speaker will comment on FDA’s inspectional practices for drugs and for devices the speaker will cover quality system issues in an international setting.
Regulatory compliance is the extent to which a company follows laws that guide an activity. While the term can refer to many different areas of industry and commerce for this discussion we will focus on drugs and medical devices.
The FDA is responsible for regulating the safety of food, drugs, cosmetics, biological products, medical devices, and consumer products that emit radiation – and It has the power to establish federal rules and regulations about these products. FDA compliance is the act of following these regulations.
Lastly, compliance is dynamic, both subjective and objective and in the end, it can have unexpected and detrimental effects on a wide variety of topics, activities and corporate reputations.
- Compliance and Trends
- Inspectional practices
- Emerging issues
- Technical focus
- Product comparisons
Course Level - Novice to senior-level personnel will benefit from this webinar.
Who Should Attend
- Audit and Compliance Personnel
- Quality Systems Managers
- GMP Specialists
Why Should Attend
Updates and discussions on compliance benefit a large audience. The ever-changing legal landscape set against active regulatory expectations presents challenges for everyone.
This seminar will compare and contrast drugs and devices, it will present the latest FDA activities in terms of numbers, statistics and trends and lastly it will cover emerging issues for both types of products.