Bioinformatics / Pharma Info - David Woodsmall

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COPYRIGHT 1992 thru 2017 - David R. Woodsmall

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References Standards Testing Programming Networks Glossary

JUMP TABLE

21 CFR part 11 | cGMP - Current Good manufacturing Processes | Change Control (Pharma) | Change Management | RTP Area EVENTS / SEMINARS | EVENTS / SEMINARS | GMP - Good manufacturing Processes | GUIDELINES | HACCP - Hazard Analysis and Critical Control Point | STANDARDS | NEWS | ORGANIZATIONS | BIO / Pharma QA Organizations | QA/Testing Organizations | QA/Testing - non-Pharama | SOP - Standard Operating Procedures | SSOP - Sanitation Standard Operating Procedures | TERMS | Medical NEWS/Links | Major Biological Data & Information Sources | XML | OTHER REFERENCES |

GUIDLINES

Pharma Group Issues Guidelines about free gifts (pens, etc) New Federal Guidelines For Physician-Pharmaceutical Industry ... Pharma Guidelines - Skyscape FDA issues new guidelines to Pharma, DME providers Guidelines for Process Hazards Analysis (PHA, HAZOP), Hazards Identification, and Risk Analysis

BIO / PHARMACEUTICAL STANDARDS

SORRY - Just noticed some dead links here - I'll soon fix them

FREE e-HIM practice standards - AHIMA ASTM International Establishes New Subcommittee on Pharmaceutical Standards - 2006 Audit Trails Biotech & Pharmaceutical Standards - complianceonline.com CRO Group - Documents 21 CFR Part 11 - compliance 21 CFR Part 11 21 CRF Part 11 - Electronic Signature / Electronic Records 21 CFR part 58 (Title 21) 21 CRF 803 - Adverse Event Reporting (FDA's MDR) 21 CRF 820 45 CFR Parts 160, 162 & 164 45 CFR part 164 - selected provisions CDER - Center for Drug Evaluation and Research (FDA) cGMP, Pharmaceutical (FDA) Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals cGMP Notes (Pharmacast) cGMP EN46001 (European standard) FDA FDA- Alphabetical Index *** FDA Guuidance Documents FDA - Computer validation resources Guidance Documents - FDA - pdfS FTC - Federal Trade Commission HIPAA: Regulations found at 45 CFR 160, 162, and 164 Tripwire HIPPA Security Standards Solution for Section 164 HL7 - Health Level 7 dot org ISO 9000 - 9003 ISO 9001-2000 Mapping ISO 9000-2000 to ISO 9001 Risk Management - Division of Compliance, FDA ISO 13485 Pharmaceutical and Biotech Industry Standards Pharma Standards - usp.org X12N - (ANSI X12 subcommittee N covers standards in the insurance industry, including health insurance; hence these are X12N standards.) X12N transaction standard - HIPPA Privacy X12N 837 - Health Care Claim, Dental X12N 837 - Health Care Claim, Professional X12N 837 - Health Care Claim, Institutional

BIO / PHARMA ORGANIZATIONS

American Diabetes Association AHIMA - American Health Information Management Association American Lung Association American Medical Association BioPerl Project Utilizes & Discusses XML Council for Responsible Nutrition DIA European Bioinformatics Insititute (EBI) of EMBL European Molecular Union Laboratory - EMBL FDA - Food and Drug Administration FTC - Federal Trade Commission HIM - Health Information Management ISBM - International Society for Computational Biology ISPE - The Society for Life Science Professionals John Hopkins Medicine National Center for Biotechnology Information - NCBI National Center for Health Statistics National Institute of Health NCCSQA - North Carolina Chapter of the Society of Quality Assurance NCHICA - North Carolina Healthcare Information and Communications Alliance, Inc NCRAF - North Carlina Regulatory Affairs Forum New England Journal of Medicine PDA Pharma Pharmaceutical Research and Manufacturers of America - PhRMA.org USP - U.S. Pharmacopeia - the standard of quality WEDI Snip

RTP Area - BIO / PHARMACEUTICAL /QA EVENTS / SEMINARS

ASQ Monthly Meeting Schedule NC regulatory Affairs Forum PDA SouthEast Quarterly Meeting at NCSU McKimmon Center Triangle Information Systems Quality Association (TISQA) Association of Clinical Research Professionals North Carolina Chapter of the Society of Quality Assurance - NCCSQA

BIO / PHARMACEUTICAL EVENTS / SEMINARS

Bionformatics Open Source Conference Complying with cGMP and GMP Requirements (seminars) - PTI cGMP - Writing and Auditing cGMP Documentation (seminars) - PTI Global GMP Expertise

BIO / PHARMA NEWS

Biotechnology Industry Organization BioSpace ClinicalTrials.Gov FDAnews Hire Health NC BIOTECHNOLOGY CENTER **

GMP - Good manufacturing Processes

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug Administration. cGMP (or CGMP) = Current Good Manufacturing Processes HACCP - Hazard Analysis and Critical Control Point. Hazard Analysis & Critical Control Points (HACCP) Hazard Analysis and Critical Control Points - Wikipedia International HACCP Alliance Sample HACCP-Based SOPs SOP - Standard Operating Procedures SSOPs = Sanitation Standard Operating Procedures (SSOPs) under FSIS requirements

GMP BACKGROUND / TUTORIALS

READ THESE:

What Is GMP? Good Manufacturing Practice - Wikipedia EU: GMP Guidelines WHO: GMP Guidelines OTHER GMP BACKGROUND & TUTORIAL INFORMATION: MHRA Good Manufacturing Guide (GMPs) Developing Good Manufacturing Processes Therapeutic Goods Association: Good Manufacturing Practices FDA: Good Manufacturing Practices Health Canada: Good Manufacturing Practices Quality Systems Regulation - Good Manufacturing Practices (GMP) / Quality Systems (QS)

GMP REFERENCES

Peruse the GMP regulations! 21 CFR Parts 4 21 CFR Part 110 (Food Industry) 21 CFR Part 111 21 CFR Parts 210 (Drug Industry) 21 CFR Parts 211 (Drug Industry) 21 CFR Part 820 (Medical Device Industry) 21 CFR Part 606 (Blood Industry) Pharmaceutical Inspection Cooperation Scheme: GMP Guides

GMP - SEE ALSO:

CAPA - Corrective and preventive action (CAPA) EudraLex Food safety GAMP - Good Automated Manufacturing Practice (GAMP) Packaging Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Validation (drug manufacture) V&V - Verification and validation The MPRF Library - a library for multiple-precision complex arithmetic based on the MPFR & GMP libraries Device Advice: Device Regulation and Guidance - FDA Dietary Supplement Current Good Manufacturing Practices (CGMPs ... - FDA

MEDICAL NEWS/Links

American Diabetes Association American Lung Association American Medical Association Council for Responsible Nutrition Food and Drug Administration John Hopkins Medicine National Center for Health Statistics New England Journal of Medicine National Institute of Health WebMD
Blue Cross and Blue Shield Bristol-Myers Squibb Merck Pfizer

BIO / PHARMA TERMS

Dave's Acronyms / Glossary / Dictionary /... Biomedical Acronym Database CAPA - Corrective Action Preventative Action - FDA. What is an FDA CAPA - WikiAnswers Medi-Lexicon Acronyms (FDA) Biochemistry and Molecular Biology bioinfo_glossary Biotech Information Resources - Federal Systems Biotech Terms biotechnology and genetic engineering glossary Biotechnology Terms Chemistry, General Chemistry Glossary CRO - clinical research organizations ;; contract research organizations EPA: Environmental Protection Agency Glossary Food - glossary Genetics Glossary Genome Glossary Immunology Glossary Managed Care and Healthcare Terminology medical terms Medicare.gov - Glossary Definitions Microbiology Glossary MSL - Medical Science Liaison NDIA A-Z LIST New Drugs/Equipment/Procedures Terms Glossary OIG - Office of Inspector General organic compounds - Glossary of Class Names of... Toxic Substances and Disease - ATSDR Virology Glossary Zoology Glossary

Change Control (Pharma)

Change Control Frequently Asked Question and Answer Doc Change Control Hot Topics-FDA/Global Regulatory Inspections GMP, GCP, GLP "How To" Articles Request to Join our GMP Training CONTENT Group - LINKEDIN

Major Biological Data & Information Sources

2D-PAGE - SWISS 2DPAGE Biochemical and Biophysical Information - ENZYME Biochemical and Biophysical Information - BIND Biochemical Pathways - PathDB Biochemical Pathways - KEEG Biological Literature - PubMed Entrez Structure DB - PROWL Genome Sequence - Entrez Genome Genome Sequence - TIGR databases Linkedin - Request to Join our GMP Training CONTENT Group Microarray - Gene Expansion Links Nucleic Acid Sequence - GenBank Nucleic Acid Sequence - SRS at EMBL/EBI Post-translational Modifications - RESID Protein and Peptide Mass Spectroscopy Protein Sequence - GenBank Protein Sequence - SWISS-PROT at ExPASy Protein Sequence - PIR Protein Structure - Protein Data Bank Web Resources - EBI Biocatalog Web Resources - IUBio Archive WIT is superceeded by both "the SEED" and "PLUMA2".

OTHER RESOURCES - Caveat Emptor

Medical Software Web Resource hipaa database schema opensource public MYGALE

A FEW OF MY OTHER WEB PAGES - DAVID WOODSMALL

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