Bioinformatics / Pharma Info - David Woodsmall
8/03/2019 - Optimized for Firefox 68.0.1
COPYRIGHT 1992 thru 2019 - David R. Woodsmall
Feel free to link to any of my pages
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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
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