Experience in Working with State. Local or other Federal Agencies
They have conducted various joint inspections with inspectors from the Puerto Rico and the U.S. Virgin Islands Health Departments to train them in inspectional sampling and investigation techniques including the proper use of sampling equipment such as UV lights, sieves, and others. At times, they have contacted these State Agencies for assistance in the immediate embargo of adulterated foods and drugs, to assure the holding of lots pending FDA action.
The experience with Federal Agencies has consisted of coordinating the cooperation of agencies such as the U. S. Customs, FBI, and USDA for the accomplishment of several inspections/investigations. For example, they worked extensively with some FBI agents during October 1987 to obtain information on a major counterfeit operations taking place in San Juan, Puerto Rico.
During 1986 and 1987 they participated with U.S. Customs agents in the investigation of smuggling of illegal conch meat from the Dominican Republic and the introduction of mercury contaminated swordfish into the U. S. market.
Experience in Monitoring FDA Programs and Managing Special Project
They were the Low Acid Canned Food Coordinator for the FDA San Juan District from 1982 to 2001 and as such they coordinated meetings with people from industry to give them information on the Low Acid Canned Food Regulation and requirements. They provided guidance and instructions for establishment registration and scheduled process filling.
They worked directly with the FDA San Juan District Director. They set priorities on the work assigned based on the nature of the assignment, the human resources available and the districts obligation under the different agency programs. They issued assignments and monitored their completion. They prepared action reports on the cases being handled by investigators. They attended the districts staff meetings and reported on the work being accomplished. Also they evaluated employees and made the selection to submit candidates for training. They prepared the quality assurance review and answered inquiries from consumers, industry and other government agencies.
They were the FDA San Juan District Import Program Manager from 1990 to 2001. In this capacity they had oversight of the entire FDA San Juan District Import program dealing with over 30 importers, entry filers and US Customs. They managed the FDA electronic systems (OASIS) that interfaces with the Customs System (ACS) and the Customs Brokers (ABI) to expedite the screening of FDA regulated entries.
After their retirement from FDA, They have provided professional services as a Senior Consultant to domestic and foreign Pharmaceutical plants in the area of CGMP compliance for finished drug products and APIs. They have also provided training in the areas of cGMP and regulatory compliance areas to operators.
Jun 2011 to present
Senior Compliance Consultant, Quality System and Compliance
- Participated in a project of a large pharmaceutical firm relating to upgrading systems and programs in response to FDA 483 Observations issued during two inspections issued between June 2011 and July 2012. The areas covered during this period were protocol execution relating to remediation in Consumer Complaint procedures/ investigations, CAPA’s and change control procedure evaluations and assessments.
Jan 2006-April 2006
Regulatory Compliance Consultant, GlaxoSmithKline
- Provide support to the QA CAPA/Investigations functional unit in gathering the evidence from the responsible units to close open corrective/preventive action deemed necessary as a result of events and event investigations action plans. Make sure such evidence meets regulations and resolve the situation they were designed to resolve.
2002 - 2005
Senior Regulatory Consultant, Schering-Plough, Manati, Puerto Rico.
- Assist firm's management in areas related to cGMP compliance to respond to the FDA Consent Decree and successfully obtain firm certification.
- Conduct internal audits of facility to assure compliance with cGMPs.
- Review documentation generated to respond to FDA observations to determine adequacy of response.
- Prepare written responses to FDA observations presented to the agency 1990 – 2001
Supervisory Investigator/Import Program Manager FDA, San Juan District
- Coordinated and oversaw multiple inspections and investigations by staff.
- Liaison person between San Juan District and the Puerto Rico Government agencies. Selected to be a member of the FDA/OIG Generic Drug Investigative Task Force.
- Managed the district's import program operations.
- Implemented the Imports OASIS electronic system to interface with the ACS/ABI systems to carry out import operations at the FDA, San Juan District Office.
- Provided training relating to the OASIS system and general import
- Regulations to the Sam Juan Import community including API registration and Listing and related regulation and guidelines.
- Review and approved investigative reports of Pharmaceutical and Medical
- Device industries written by FDA investigators to determine adherence to the CGMP requirements and agency policies.
- Developed and presented training in the area of food and drug CGMPs to respective regulated industry.
FDA, San Juan District
Conducted inspections and investigations of complex generic and brand name Drug establishments, developed investigative plans and collected samples to support findings applying CGMPs, Regulatory Agency Guidelines and Procedures.
Consumer Safety Officer San Juan District, FDA
- Concentrated in the food program area with the emphasis given to The Low Acid Canned Foods (LACF) and food microbiological issues.
- LACF coordinator and field contact person.
San Jua FDA District Office Consumer Safety Inspector KEY RESPONSIBILITIES
- Collected hundreds of samples of food, cosmetics, and drug products.
- Traced business transactions and gathered interstate documentation.
- Conducted sanitary, inspections of warehouses, bakeries, and food manufacturing facilities.
- Conducted basic GMP inspections of cosmetic and drug manufacturing plants.
District Purchasing Agent FDA, San Juan District
- Assisted the Administrative Officer in acquiring office and scientific supplies and equipment.
- Maintained accountability records for office and scientific equipment.
EDUCATION and TRAINING
- BS in Business Administration, Inter-American University -1972
- Criminal Investigator's School, Federal Law Enforcement Training Center, Glynco, GA 1988
- Auditing Pharmaceutical and Device Quality Systems, University of Rhode Island 2000
- Quality Systems and Auditing, GMP Institute, 1998
- Drug Manufacturing Quality Control, Ferris State College, Michigan, 1984
- Food and Drug Law, Public Health Service, FDA, 1986, San Juan, PR
- Seminar for Managers, 1994, Public Health Service, FDA, Oak Ridge, Tennessee
- Process Control Systems, 1985, the Foxboro Company
- Applied Epidemiology, Center for Disease Control, 1982, Columbus, Ohio
- Pharmaceutical Manufacturing and Quality Control, Public Health Service, FDA, 1979, San Juan, PR
- Legal Aspects of Enforcement, Public Health Service, FDA, San Juan, 1984
- Import Enforcement Procedures, Public Health Service, FDA, 2000, Gaithersburg, MD
SENIOR QUALITY ASSURANCE AND COMPLIANCE PROFILE
- A former FDA Investigator/Supervisory Investigator with 28 years of experience in the pharmaceutical, biotechnology and medical devices industries. In addition, experienced in the Regulatory Industry to include Quality Assurance, Quality Control, Regulatory Compliance, and Manufacturing Operations...
- Auditing of the Pharmaceutical Industry (drugs, devices and biologics) to assure compliance with the Food and Drug Administration regulations and Policies
- Training and experience in the criminal investigations area focused in fraud and falsification of production records
- Experience in the Consent Decree environment as member of the certification team to the FDA for a large pharmaceutical plant
Superior communication skills in both Spanish and English