Patrick Weixel Email & Phone Number

Clarksburg, Md, Us

Silver Spring, Maryland, United States

Manage the CQS team that is responsible for evaluating regulatory actions such as warning letters for supportability and that the appropriate violations are cited.Work with the Associate Director to develop strategic priorities for the Center and Compliance and Quality StaffEvaluate the supportability of enforcement actions (eg. Injunctions) and monitor ongoing judicial actionsWork closely with other offices such as the Office of Chief Counsel to review and edit case documents such as Consent Decrees.Develop mitigation strategies to avoid potential supply chain issues.Provide training to Industry on topics such as sterilization and packaging.Provide training to CDRH staff on compliance assisgnments process and ensuring proper evidence development.Standards Development - work with industry, academia, and end users in the development of medical devices and validation of processes. FDA Primary Representative for the following committees Association for the Advancement of Medical Device Instrumentation Working Group 2 - Radiation Sterilization - for 20 years. ASTM International F02 - Primary Barrier Packaging - 20 yearsASTM International E61 - Radiation Processing - 17 yearsSelected as a member of the USA Delegation for multiple ISO Technical Committee 198 meetings for Working Group 2 - Radiation Sterilization and Working Group 7 - (Medical Device) Packaging

Silver Spring, Maryland, United States

Review regulatory actions for concurrence and to ensure the appropriate regulatory citations are being cited. Work with the Associate Director of CQS to develop policies and procedures for compliance activities. Mentor and train staff that perform compliance type assignments such as Establishment Inspection reviews.Reviewed Medical Device Single Audit (MDSAP) regulatory audit reports to determine Business Process Improvements for audit reports with significant nonconformances. Mentored staff on compliance assignment activities and evaluating evidence in Establishment Inspection Reports to determine if regulatory actions are warranted.Evaluated Emergency Use Authorization submissions during the COVID-19 pandemic.

Silver Spring, Md

Provided management support to the Medical Device Single Audit Program team, Exports, Imports and Registration and Listing teams.Tasked to address complex assignments under short timeframes.Developed response to an inquiry on an ethylene oxide sterilization facility.Worked with the Division Director to develop policy for the reorganizational structure of the Office of Product Evaluation and Quality. Involved in Business Process Improvement activities for compliance activities.

Silver Spring, Md

Oversee the compliance assignments for the Office of In Vitro Diagnostics to ensure regulatory actions are appropriate and can be supported. Provide training to staff and identify resource and guidance to help staff improve their reviews of compliance assignments.

Silver Spring, Md

Responsible for developing policies and strategies for compliance assignments and work activities. Helped develop recommendations on conducting joint Quality System (QS) and Electronic Product Radiation Control Inspections.Develope work instructions for compliance assignments.Train reviewers on compliance related subjects as well as work instructions. Responsible for making recommendations on the appropriate regulatory actions for device manufacturers that are not in compliance with QS and/or Rad. Health regulations.Conduct sterilization and packaging consults. Participate in training to FDA personnel and industry on subjects such as the Quality System regulation, Sterilization, and Radiological Health regulations. Selected as a member of several ORA Course Advisory Groups that develop training material for FDA device investigators.

Silver Spring, Maryland, United States

Review Medical Device Establishment Inspection Reports to determine the supportability of QS observations and classification of the inspection.Determine if regulatory actions such as seizures and injunctions can be supported by CDRH. Determine the classification of Medical Device recalls.Conduct Sterilization, Packaging (sterile barrier system) and Reprocessing of Single Use Device consults.Provide training to FDA and the Medical Device Industry in areas such as Medical Device Quality Systems regulation (21 CFR 820), sterilization and packaging validation, and medical device recalls.Participate in the development of standards in areas such as Sterilization of Healthcare Products - Radiation, Test Methods used on Sterile Barrier Systems, and Dosimetry standards.

I evaluated review memos to ensure the appropriate QS regulation was cited and to ensure the recommended EIR classification was appropriate.I determined if CDRH could support regulatory actions such as seizures and injunctions.Conducted training for FDA and the Medical Device industry in areas such as Quality System regulation, Sterilization, Packaging and recalls.Conducted Sterilization and Packaging reviews.

Rockville, Md

Reviewed Establishment Inspection Reports, to determine significance of violations and recommended regulatory actions when significant violations were observed.Conducted Sterilization reviews for the General Hospital Devices Branch and reviewers within other branches.Provided training in areas such as Quality System regulation and Sterilization to CDRH personnel and industry.Assisted in the development of Industrial Sterilization standards.Conducted reviews of 30-day notice premarket approval submissions.

Falls Church, Va

Inspected medical device manufacturers to determine compliance with good manufacturing practice regulation, medical device reporting of adverse events and other regulatory requirements.Worked with U.S. Marshalls to seize violative drugs due to violations observed during an inspection I performed.Performed consumer complaint investigations to determine if further follow-up may be need at the manufacturer.Conducted recall audit checks to determine if the recalling firm's recall notification was effective.

Philadelphia, Pennsylvania, United States

Inspected food, medical device and drug manufacturers and blood banks, to determine if the firms are in compliance with the Food, Drug and Cosmetic Act and good manufacturing practice regulations.Collected food samples for analysis of pesticides, aflatoxins and filth.Conducted recall audit checks to determine the recall notifications were effective. Conducted a 2 month detail as the consumer complaint coordinator.Investigated a high profile consumer complaint with the Office of Criminal Investiagation, which resulted in an arrest.