- PROVIDE QA LABORATORY OVERSIGHT ON RAW MATERIALS, FINISHED PRODUCTS, AND DEVELOPMENT LABS INCLUDING MICRO AND STABILITY LABS.- GUIDE THE LABS ON HOW TO WRITE EFFECTIVE DEVIATION REPORTS.- TRAIN THE LABS ON GOOD MANUFACTURING PRACTICES AND COMPENDIAL REQUIREMENTS IN USP, BP, JP, EP, AND ROW (REST OF THE WORLD).- ENSURE THAT THE COMPANY IS IN COMPLIANCE WITH REGARDS TO WORLDWIDE COMPENDIAL COMPLIANCE: USP, BP, JP, EP AND ROW (REST OF THE WORLD).- EXPERTISE ON THE USE OF VARIOUS LABORATORY EQUIPMENT.- FORTE IN THE DEVELOPMENT, VALIDATION, AND IMPLEMENTATION OF ANALYTICAL PROCEDURES.- VAST KNOWLEDGE OF MANAGEMENT SKILLS IN PRODUCTION, QC, DEVELOPMENT, AND QA.

- PROVIDE TRAINING ON GOOD LABORATORY PRACTICES (GLP/CGMP).- CONDUCT COMPENDIAL TRAINING (USP, NF, Ph. Eur., BP, JP, JPED, JPE, FCC, PHARMACOPEIAL FORUM PHARMEUROPA , JAPANESE PHARMACOPEIAL FORUM ).- CREATE A COMPENDIAL SYSTEM ON ALL COMPENDIAL AIS, EXCIPIENTS, AND FINISHED PRODUCTS AND ENSURE THAT CURRENT REQUIREMENTS ARE MEET.- DEVELOP TRAINING ON DIFFERENT LABORATORY INSTRUMENTS SPECIALLY ON DISSOLUTION AND AUTOANALYZER. - AFFORD TECHNICAL EXPERTISE ON METHODS VALIDATION, METHODS TRANSFER, AND CLEANING VALIDATION. - TROUBLESHOOT LABORATORY PROCEDURES, LABORATORY EQUIPMENT, AND PRODUCTION PROBLEMS.- REVIEW AND CRITIQUE TECHNICAL REPORTS TO ENSURE THEY ARE ACCURATE AND COMPLETE.- FACILATATE THE TECHNICAL REVIEW OF THE CMC DOSSIER FOR REGULATORY SUBMISSIONS. - ASSIST ON THE WRITEUP AND CAPA ON OOS/SUSPECT REPORTS AND DEVIATION REPORTS.

- PROVIDED QA LABORATORY OVERSIGHT ON THREE LABORATORIES (RAW MATERIALS, FINISHED PRODUCTS, AND DEVELOPMENT LABS) INCLUDING MICRO AND STABILITY LABS.- GUIDED THE LABS ON HOW TO WRITE EFFECTIVE DEVIATION REPORTS AS WELL AS TO AVOID MISTAKES.- TRAINED THE LABS ON GOOD MANUFACTURING PRACTICES AND COMPENDIAL REQUIREMENTS IN USP, BP, JP, EP, AND ROW (REST OF THE WORLD).

- ENSURED THAT THE COMPANY IS COMPLIANT WITH ALL COMPENDIAL COMPLIANCE REQUIREMENTS (USP, NF, BP, Ph. Eur., JPED, EP, ROW, and Pharmacopeial forum- PROVIDED LABORATORY OVERSIGHT OF ALL 3 LABORATORIES (RAW MATERIALS, FINISHED PRODUCTS, DEVELOPMENT LABS) INCLUDING BIOLOGICAL LABS AND STABILITY LABS.

- HIRED AS THE FIRST OFFICIAL COMPENDIAL COMPLIANCE COORDINATOR AT THIS PHARMACEUTICAL PLANT.- REVIEWED SEVERAL HUNDREDS OF EXISTING SPECIFICATIONS AND TESTING INSTRUCTIONS OF RAW MATERIALS AND FINISHED PRODUCTS OF CATALYTICA PHARMACEUTICALS AND DETERMINE IF THEY COMPLY WITH THE EXISTING COMPENDIAL REQUIREMENTS (USP, EP, BP, JP, ROW).- REVISED THOSE SPECIFICATIONS AND TESTING INSTRUCTIONS THAT WERE NON-COMPLIANT AND EXPEDITE THE PROCESSING OF THE REVISED VERSIONS.- ORDERED BOOKS AND FORUMS TO KEEP UP WITH ALL COMPENDIAL CHANGES.- TRAINED THE LABS ON COMPENDIAL REQUIREMENTS AND GOOD MANUFACTURING PRACTICES.

- HIRED, TRAINED, AND NURTURED TALENTED SCIENTISTS WHO WERE WILLING TO LEARN AND WORKED HARD, AS WELL AS AMBITIOUS TO BE SOMEBODY SOMEDAY. AMONG THOSE THAT WENT ON TO HIGHER POSITIONS ARE PHIL HODGES, WAYNE TALTON, KIMBERLY TYNDAL, DAVID CUMMINGS, JOHN CLARKE, TOBY HOLIDAY, STEVEN EDWARDS, LINDA PROCTOR, AND NUMEROUS MEDICAL STUDENTS DURING SUMMER - INTERNS. HIRED, TRAINED, AND NURTURED HUNDREDS OF TEMPORARIES THAT WERE PLACED ON PERMANENT JOBS IN OTHER AREAS OF THE COMPANY. - IMPLEMENTED NEW TECHNOLOGIES BY ATTENDING TRAINING, MEETINGS, AND CONFERENCES.- IMPLEMENTED NEW TECHNOLOGIES BY ATTENDING CLASSES/TRAININGS ON NEW EQUIPMENT, TECHNOLOGY TO THE LABS.- DEVELOPED AND VALIDATED AUTOMATED ANALYTICAL PROCEDURES FOR MOST BURROUGHS WELLCOME PRODUCTS WHICH ARE NOW IN THE USP TESTING AND SPECS PROCEDURES.- WORKED WITH MR. JIM MURPHY, THE DEPARTMENT HEAD ON THE LOOSENING UP THE CONTENT UNIFORMITY SPECIFICATIONS IN THE USP, TO THE DELIGHT OF THE PHARMACEUTICAL INDUSTRY.- DISSOLUTION PROCEDURE FOR LANOXIN TABLETS IS THE FIRST DISSOLUTION PROCEDURE IN THE USP. WORKED WITH MR. JIM MURPHY ON THE FINAL DISSOLUTION PROCEDURE FOR THIS BURROUGHS WELLCOME PRODUCTS.- WITH BURROUGHS WELLCOME LEAD - JAIME LAGASCA REPRESENTING BURROUGHS WELLCOME, MAJOR PHARMACEUTICAL USP FOCUS GROUP CAME TO THE IDEA OF INCLUDING DISSOLUTION PROCEDURES FOR ALL SOLID DOSE FORMULATIONS AS ONE OF THE REQUIREMENTS FOR TESTING. STUDIES WERE CONCENTRATED ON THE BASKET OR PADDLES DISTANCE TO THE BOTTOM OF THE VESSELS, TYPE OF EQUIPMENT, TEMPERATURE, DISSOLUTION MEDIA, ETC. IT TOOK SEVERAL YEARS TO COMPLETE THE STUDIES AND THE PROCEDURES TO BE INCORPORATED IN THE USP.- AUTHORED HUNDREDS OF DOCUMENTS FOR IND, NDA, ANDA, ETC. FDA SUBMISSIONS .- AUTHORED HUNDREDS OF CERTIFICATES OF ANALYSES OF PRODUCTS THAT WENT TO PHARMACEUTICAL INDUSTRY , GOVERNMENT AGENCIES, AND OTHER INDEPENDENT AGENCIES. - PASSED ALL GOVERNMENT FDA PRE APPROVAL INSPECTIONS OF BURROUGHS WELLCOME PRODUCTS BEFORE MARKET LAUNCH.-