United States
- International speaker, mentor and coach for topics on IR pitch deck, FDA regulatory, quality, clinical, CGMP, regulatory compliance, FDA inspection and 483s. - President and principal, REGULATORY DOCTOR, an international and FDA regulatory consulting firm (http://www.RegulatoryDoctor.US). - Certified in regulatory affairs (RAC) and quality (ASQ-CQA) - Licensed to practice patent cases (USPTO) - Provide practical, actionable, and sustainable solutions (PASS) for 510k, PMA, GLP, CGMP, FDA inspection, drugs, biologics, biosimilars medical devices, cosmetics and combination products - Provide regulatory and quality training to FDA regulated industry (drug and medical device manufacturers) - Provide extensive consulting and training services in global laws and regulations, food, drugs, biologics, biosimilars, cosmetics, combination products and medical devices including IVDs. - FDA speaker and FDA expert consultant for FDA premarket notification 510k, premarket approval PMA, FDA inspection, FDA 483s and warning letters, device design control, biocompatibility, unique device identification (UDI), complaint handling, MDR, ISO 13485, ISO 14971, risk management, FDA QSRs, CAPA, GLP, GCP, GMP, pharmacovigilance, labeling, advertising and promotion, FDA regulatory process for drugs and medical devices/IVDs, FDA advisory committee meeting for logistics and outcome analysis, branding, R&D, CE mark, clinical evaluation, management consulting - US FDA ● Health Canada ● EMA ● TGA ● MFDS ● CFDA ● CDSCO ● ANVISA ● ANMAT ● COFEPRIS ● TFDA ● PMDA - Help global and FDA-regulated industry do better and easier and sustain - Visit us at http://www.regulatorydoctor.US or E-mail us at [email protected]
Colon cancer diagnostics, regulatory strategy development, FDA submissions and FDA communications
At FDAnews, Inspection Insider provides the latest, best quality of key news on FDA inspection matters. - http://inspections.fdanews.com/ - http://inspections.fdanews.com/experts
- FDA Regulatory, Quality and Compliance Matters - Medical Device Regulatory Process - Drug Regulatory Process - Packaging and Labeling - Medical Product Development - FDA Enforcement Matters
- Presents on FDA 510(k)s and PMA; EU medical devices (MDD, Directive 93/42/EEC); EU in vitro diagnostic medical devices (IVDD, Directive 98/79/EC); EU active implantable medical devices (AIMDD, Directive 90/385/EEC) - FDA GLP, GCP and cGMP - FDA 21 CFR Part 820: QSRs - Adverse event reporting (vigilance/surveillance system) in EU, Canada and US (MDR) - Global medical device regulations (US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, and Taiwan, etc.) §§TESTIMONIALS§§ ❶ “Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.” By QC/RA Mgr. ❷ “Dr. Lim was great. The event was well organized and coordinated. I would recommend this to others.” By Attorney ❸ “I enjoyed it very much.” By Dir. of RA/QA ❹ “I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.” By QC/RA Mgr. ❺ “My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. I would also like to recommend this seminar to others.” By RA Mrg. ❻ “Dr. Lim was very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.” By RA Mgr. ❼ “I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated.” By QA Analyst ❽ “All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. Dr. Lim is an excellent friendly presenter. Overall it was good value for the price.” By Managing Dir. ❾ “Thanks for organizing it very well and professionally. I would like to attend next seminar.” By Mfg. Engr.