Dusty Snoeberg-Renwick has more than 25 years of combined FDA and industry experience regarding interpretation and implementation of FDA regulatory requirements. She has expertise in pharmaceuticals, medical devices & bio-technology implementing successful quality systems and working with firms executive management and FDA to resolve FD-483, Warning Letter & Consent Decree issues.
While working as an FDA Investigator, Dusty was considered an expert in process validation and GMP compliance. While working with industry, she helped to extricate the first medical device firm placed in a Consent Decree. She knows how to efficiently assess and implement compliant quality systems. Dusty has a Bachelor of Arts General Science degree from Wright State University and attended Master level courses in Pharmaceutical Manufacturing at the University of Cincinnati.
Lisa Hornback has more than 20 years combined FDA and industry experience with both pharmaceutical and medical device firms. She is an expert in QSIT/GMP/ISO compliance and has guided companies through resolution of Warning Letters and Consent Decrees by implementing successful and compliant quality systems.
Lisa was considered an expert in both medical device and pharmaceutical quality systems while working at the FDA. She holds a Bachelor of Science Medical Technology degree.
Tim Couzins is a retired FDA Investigator and Compliance officer. He brings more than 30 years of both FDA and Industry experience. He is knowledgeable with pharmaceutical and medical device regulatory and GMP requirements and has experience implementing high quality, compliant systems.
Tim is known for his expertise, skill and ability in resolving FDA 483, Warning Letter and Consent Decree issues by interacting directly in a firms behalf with the FDA. Tim has a Bachelor of Science degree from Xavier University.
Steve was a former FDA Investigator and has both FDA and industry experience. His expertise is with Class III medical device products from regulatory strategy development through pre/post requirements. He performs Mock-FDA audits for medical devices, Human Tissues and complex high risk (HACCP) foods.
He is experienced with writing technical documents required for US and EU PMA/510k submissions and has expertise with ISO 13485. Steve has also helped firms build quality systems that have passed FDA scrutiny. He holds a BS in Molecular Biology from the University of Colorado.
Jennifer has more than 18 years combined FDA and Industry experience with Pharmaceuticals, medical devices, biologics and bio-research clinical regulatory requirements. During her 10 years tenure with FDA, she conducted many inspections covering all product areas and was considered expert in BIMO, GMP and GCP audits.
Jennifer is considered an expert in assessing compliance issues and implementing corrective actions/quality systems to resolve problems. She holds a Bachelor of Science degree from Florida State University.
John Crowe is a retired FDA Investigator and forensic chemist with more than 33 years of combined FDA and industry experience in pharmaceuticals, BIMO, laboratory compliance and dietary supplement audits. He has expertise in implementation and interpretation of FDA regulatory requirements and is considered an expert in BIMO. John is knowledgeable in quality systems and can conduct mock FDA inspections regarding pharmaceuticals, BIMO, dietary supplements, laboratory and corrective action implementation.
John holds a Bachelor’s degree in Forensic Chemistry from Eastern Kentucky University. As a research chemist with the FDA’s Forensic Chemistry Center, he was involved with the implementation of the FDA’s tobacco regulations, as well as a lead chemist with: melamine in pet food; over-sulfated heparin; counterfeit drug and packaging identification; Ma Huang; and hundreds of other formulation issues with dietary supplements. John has been published over 20 times in internal and peer review journals and is an accomplished researcher and problem solver.
Marianne is a former FDA (retired) Investigator and she spent 25+ years inspecting pharmaceutical, biologics, bioresearch and food manufacturers. In addition to being an Investigator, she
held the position of Deputy Director of Investigations Branch.
Marianne has expertise in assessing compliance issues and implementing appropriate corrective actions (CAPAs); responding to FD-483’s and warning letters.
Chris is a Quality Assurance and Regulatory Affairs accredited (CQE and RAC) professional with more than 30 years combined FDA and Industry experience. His expertise expands across a wide area of compliance regarding pharmaceuticals such as: Mock FDA GMP audits (production & laboratory) and Clinical trial GXP & GCP audits.
Chris also worked in Regulatory Affairs in industry and has successfully submitted and received approval from the FDA for regulatory documents such as NDAs, ANDAs, INDs, IMPDs, CTDs, MAs, DMFs and Amendments & Supplements. He works with Executive management advising and writing responses to FDA-483s, Warning letters and attends FDA meetings with clients.
Chris has a Master’s Degree in Microbiology from Wayne State University, Detroit, MI and a BA in Biology, Michigan State. He has published articles in FDA News, Interpharm Press Inc., and other healthcare magazines.
Terri Dodds was with the FDA for 16 years primarily as a Pharmaceutical Drug Expert, as well as over seven years experience with consulting to industry. Besides Ms. Dodds’ capability in pharmaceuticals, her expertise also includes medical devices, bio-technology, and clinical studies.
Ms. Dodds performs mock-FDA audits, sterile product audits (Environmental Monitoring Evaluations), warning letter and strategic regulatory consultation, CMO and CRO audits, and the evaluation of technology transfers, scale-ups and validation plans.
Ms. Dodds holds a Bachelor of Science degrees in Nursing and Education and a Masters of Arts degree in Business.
Dr. Mastronardy has more than 25 years both FDA and Industry experience. He is an expert in providing guidance to regulatory submissions (ANDA, NDA, PMA, 483 response, consent decrees, supplements, annual reports) and writing regulatory SOPs. He worked in the Generic Drug Division while serving the FDA.
Dr. Mastronardy has quality system expertise regarding cGMP solutions for both pharmaceutical and medical devices. He conducts validity assessment audits and assists in developing QC (laboratory) specifications & method validations. He is known for his ability to assess issues timely and implement quality systems that work (pass FDA scrutiny).
Dr. Mastronardy has a Bachelor’s degree in Biology and a Ph.D/M.S Genetics.
Alex Slizza is a former FDA Investigator with 20+ years combined FDA and Industry experience. His expertise is in the medical device (QSIT) and biotech areas.
During his FDA tenure he was a member of the International Inspection Cadre.
Alex holds a Bachelor of Science, Bioengineering degree from the University of California.
Nancy is a former FDA prosecutor, defense lawyer and trade association executive with more than 20 years experience in training FDA and industry officials. She created the course: Dangerous Documents - Avoiding Land Mines in your FDA Records and Emails to make people aware of how prosecutors, plaintiff lawyers, and the media can infer inappropriate conduct from short, cryptic and sarcastic emails. She has presented the course at 75 drug and device companies, FDA staff college, public seminars and universities.
Nancy received her BS from Cornell University and her JD and LLM from New York University Law School. She received Vice President Gore's Reinventing Government Award, the FDA Commissioner Special Citation and was selected as one of the 100 most notable people in the medical device industry.