Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

 

 

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

Recorded, Available at any time

 

Understanding USP Documents and Reference Standards

General Chapters, General Notices, Monographs, Forum, Reference Standards

Recorded, Available at any time

 

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

Recorded, Available at any time

 

Learnings from Recent FDA Warning Letters Related to Computers  and Part 11

With Clear Recommendations for Corrective and Preventive Actions

April 3, 2007

 

Understanding and Implementing ISO 17025

Requirements, Strategies and and Tool Kits for Laboratory Accreditation

Recorded

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations.

Available on demand

 

 

 

With master plans, 22 SOPs, Checklists, Examples, Audio seminar

 

For FDA/EU Compliance of Excel Spreadsheets

With Video presentations, primer, SOPs, checklists and examples

 

FDA Predicate Rules

Predicate rules are the requirements that can be found in part 21 CFR Food and Drugs regulations. They are basically promulgated under the authority of the Food Drug and Cosmetic Act or under the authority of the Public Health Service Act. The most well-known FDA regulations are the GLP and GMP regulations but there are many more. All FDA regulations can be downloaded from the FDA website but sometimes they are not easy to find. Here you can find a list and links to 23 FDA regulations.

Food

 

21 CFR 106

Infant Formula Quality Control Procedures (search Google)

 

21 CFR 107

Infant Formula  (search Google)

 

21 CFR 110

Current Good Manufacturing Practice in Manufacturing, Packing and Holding Human Food  (search Google)

 

21 CFR 113

Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers  (search Google)

 

21 CFR 114

Acidified Foods  (search Google)

 

21 CFR 123

Fish and Fishery Products  (search Google)

 

21 CFR 129

Bottled Drinking Water  (search Google)

GLP

 

21 CFR 58

Good Laboratory Practice for Non-clinical Laboratory Studies  (search Google)

GMP

 

21 CFR 210

Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs

 

21 CFR 211

Current Good Manufacturing Practice For Finished Pharmaceuticals  (search Google)

GCP

 

21 CFR 50

Protection of Human Subjects  (search Google)

 

21 CFR 54

Financial Disclosure by Clinical Investigators

 

21 CFR 56

Institutional Review Boards Table of Contents  (search Google)

New Drugs

 

21 CFR 310

New Drugs

 

21 CFR 312

Investigational New Drug Application

 

21 CFR 314

Applications for FDA Approval to Market a New Drug

 

21 CFR 510

New Animal Drugs

 

21 CFR 511

New Animal Drugs For Investigational Use

 

21 CFR 514

New Animal Drug Applications

 

Medical Devices

 

21 CFR 803

Medical Device Reporting  (search Google)

 

21 CFR 806

Medical devices Reports of Corrections and Removals  (search Google)

 

21 CFR 808

Exemptions from Federal Preemption of State and Local Medical Device Requirements  (search Google)

 

21 CFR 814

Premarket Notification  (search Google)

 

21 CFR 820

Quality System Regulation  (search Google)

Other FDA Regulations

 

21 CFR 1

Exports: Notification and Recordkeeping Requirements 

 

21 CFR 11

Electronic Records/Electronic Signatures