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Member Benefits:

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FDA.Com

Food & Drug Association

Resources Global Users

Basic Membership:

Annual Subscription Cost:

  • Access to your own Personalized dashboard

  • One (1) Condition States Notifications (via email)

    • New Products & Treatments​

    • New Clinical Trials & Enrolment Information​

    • Published Articles from Doctors & Research

  • Up to Two (2) Drug / Device Product Notifications

  • Complaints, Recalls & FDA / EU Warnings

  • Personalized Notification Emails (up to 10 per month)

  • Research Library for Selected Condition States

  • Access to Federal Agency Webinars, Meetings, Conferences & Events

  • Weekly GXPNews for What's New with the FDA

  • Access to FDA.TV Basic Plan (with Advertisements)

  • General Warning Letters and Consent Decrees

  • General Recall Notifications

  • Basic Access to the Nurses Corner per Condition State

  • Stategic links to WebMD, Drugs.com, MedLinePlus, GKS & other informational sites.

  • 10% Discount on all Products

Annual Subscription Cost:

Premium Membership:

  • Access to your own Personalized dashboard

  • Up to Five (5) Condition State Notifications (via email)

    • New Products & Treatments​

    • New Clinical Trials & Enrolment Information

  • Up to Five (5) Drug / Device Product Notifications

  • Two (2) Personalized Notification Emails (up to 100 per month)

  • Research Library for Selected Condition States

  • Access to Federal Agency Webinars, Meetings, Conferences & Events

  • Weekly GXPNews for What's New with the FDA

  • Access to FDA.TV (without Advertisements)

  • Warning Letters and Consent Decrees

  • Recall Notifications

  • Stategic Condition State notification links to WebMD, Drugs.com, MedLinePlus, GKS, Mayo Clinic & other informational sites.

  • 20% Discount on all Products

FDA.Com

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Food & Drug Association

Resources for Business

Basic Business Membership:

Annual Subscription Cost:

  • Access to your own Personalized dashboard

  • Access to GMP Boot Camps Annual GMP Training

  • Up to Two (2) Governance* Notifications (via email)

  • One Handbook supporting Governance Selection

  • Personalized Notification Emails (up to 10 per month)

  • Access to SOPLibrary.com (Up to 10 SOPs per year) ****

  • Access to Federal Agency Webinars, Meetings, Conferences & Events

  • Webinar, e-Workbooks and e-Certificates of Attendance

  • Weekly GXPNews for What's New with the FDA

  • Access to FDA.TV (with Advertisements)

  • Warning Letters and Consent Decrees

  • Recall Notifications

  • Published Articles from Industry Leaders

  • Job Board Notifications supporting Member's CV***

  • Personalized Governance Links - LinkedIn, Federal Register (as per Governance), Agency Notifications, etc.

  • Access (2 per month) GXPHelpDesk.com

  • Access to GMP Suppliers Qualifications

  • 10% Discount on all Products

    • GMP Publications Handbooks​

    • GMP Boot Camp Webinars & on-site Training

    • The Auditing Group on-site Audit & Gap Analysis

    • GMP Supplies at gmpsupplies.com

    • CAPA Management Services (www.capamanager.com)

    • Discount Association Links

1

Premium Membership:

Annual Subscription Cost:

  • Access to your own Personalized dashboard

  • Access for up to five (5) Attendees - Annual GMP Boot Camps GMP / QMS & 21 CFR Part 11 Training

  • Up to Four (4) Governance* Notifications (via email)

  • Four (4) copies of the Handbooks supporting Governance Selection

  • Personalized Notification Emails (up to 10 per month)

  • Access to SOPLibrary.com (Up to 25 SOPs per year) ****

  • Access to Federal Agency Webinars, Meetings, Conferences & Events

  • Webinar, e-Workbooks and e-Certificates of Attendance

  • Weekly GXPNews for What's New with the FDA

  • Access to FDA.TV (with Advertisements)

  • Warning Letters and Consent Decrees

  • Recall Notifications

  • Access (2 per month) GXPHelpDesk.com

  • Access to GMP Suppliers

  • 20% Discount on all Products

    • GMP Publications Handbooks​

    • GMP Boot Camp Webinars & on-site Training

    • The Auditing Group on-site Audit & Gap Analysis

    • GMP Supplies at gmpsupplies.com

    • CAPA Management Services (www.capamanager.com)

2

*Up to Two (2) Condition States:

  • Acne

  • ADD and ADHD

  • AIDS/HIV

  • Allergies

  • Alzheimer's

  • Arthritis

  • Asthma

  • Autism

  • Back Pain

  • Birth Control

  • Cancer - Breast

  • Cancer - Prostate

  • Cholesterol

  • Common Cold  |  Flu

  • Crohn's & Colitis

  • Dental Health

  • Diabetes

  • Diet & Nutrition

  • Ear Disorders

  • Epilepsy

  • Erectile Dysfunction

  • Glaucoma

  • ​Hair Loss

  • Headache  |  Migraine

  • Heartburn

  • Heart Attacks

  • Hepatitis

  • Hemorrhoids

  • Kidney

  • Lyme Disease

  • Men's Health

  • MRSA

  • Multiple Sclerosis

  • Osteoporosis

  • Parkinson's

  • SARS

  • SIDS

  • Skin Care

  • Sleep Disorders

  • Smoking

  • Snoring

  • Stress | Depression

  • Stroke

  • Vitamins

  • Weight Control

Up to Two (2) Drug / Supplement / Medical Device Product Notifications:

ConditionStates
ProductNotificatons
Governance

*Up to Two (2) Governance Notifications

  • Electronic Systems Regulations:

    • 21 CFR Part 11 Electronic Records; Electronic Signatures

    • EU Annex 11

    • Software & Systems Validation

  • Good Laboratory Practice

    • 21 CFR Part 58 Good Laboratory Practice

    • OECD GLPs

    • EU Good Laboratory Practice

  • Food Industry GMPs

    • 21 CFR Part 110/117 GMPs for Food Industry

  • Dietary Supplements

    • 21 CFR Part 111 GMPs for Dietary Supplements

  • Drug Industry

    • 21 CFR Part 210/211 Drug Products GMPs

    • EU GMPs

    • EU Annex 1 Sterile Products

  • Clinical Research & Clinical Industry

    • 21 CFR Parts 312 Investigational New Drug Application

    • 21 CFR Parts 314 Applications for FDA Approval to Market a New Drug

    • 21 CFR Part 316 Orphan Drugs

  • Biologics Industry

    • 21 CFR Parts 600, 601 & 610 Biologics GMPs

    • Biologics Laboratory Safety (BLS 1, 2, 3 or 4)

  • Medical Device Industry

    • 21 CFR Part 820 Quality Systems Regulations

    • EU 2017/745 MDR

    • EU 2017/746 IVDD

    • ISO 13485 QMS Medical Device

    • Combination Devices (Select Drug or Biologics)

1 Handbooks from GMP Publications (www.gmppublications.com) 

2 Member's Section includes submittal of Resumes (CVs)

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