- Nickel Allergies - How low of a percentage of nickel can be in stainless steel?
- FDA - Change of US Agent - Don't want to use the US agent for our own products
- Retroactive application of harmonized standards
- Are there any guidelines for writing an Intended Use statement?
- FDA - Audit - Response - Observation form 483. Do we now receive a formal letter?
- Anyone have experience with ISO/IEC 15189 for medical laboratories?
- Tracebility requirements in Pharma vs Medical Devices - Nonconformance issue
- FDA is nobody's "lapdog"
- Does anyone have any information on FDA's SMG 2020 issued Oct 04.
- Is anyone out there considering using a Third-Party for their FDA Audit?
- FYI - FDANews Calls for authors
- Is a registrar obligated to inform the FDA of NCRs that could be considered 483s?
- How does the FDA's SMG 2020 compare to ISO/TR 10013:2001?
- FDA District Office - How do you know which one to contact?
- Can pharmaceutical companies delegate some responsibilities to supplier?
- Top FDA guy resigns - impact on industry?
- Instructions for Use (IFU) - On the manufacturer's website vs. On the product label
- Where to find FDA requirements for new products
- For non-US manufacturors: Statement of distributor on insert/labelling
- Temperature indication In Vitro Medical Devices USA
- How costly can a quality system problem be? Guidant vs. the FDA
- Good Manufacturing Practices - How you document your GMP's - GHP's and how detailed
- Implementation of the FDA requirements into the existing Quality Management System
- SUPAC (Scale Up and Post Approval Changes) guidelines for pharmaceuticals
- Comparison of EU and US GMPs - Differences applying CFR211 or the EU GMPs
- Correction Fluid on documents - FDA regulations?
- FDA Validation - Does one have to conduct validation for Computer Servers?
- IFU Font size - Specified by any regulations for medical devices on sale in the US?
- IS there such a thing as FDA "Good Distribution Practices"
- ISO 15378:2006, Primary packaging materials for medicinal products
- Canadian hospitals restrict the use of products that contain Lanolin?
- Auditing Pharmaceutical Toll Manufacturers
- Key Performance Indicators in a pharmaceutical company
- FDA Requirements for Document Approval by Quality Department
- cGMP and Batch Integrity of Bulk Storage Tanks
- Pharmaceutical Company Quality Manual
- Pharmaceutical & Validation Protocol Listings?
- FDA Epoxy Floor Paint Specifications
- Effective system to track a Technology Transfer to a sister plant
- Permanent Inspection Readiness for a pharma manufacturing firm
- OS Changes to Fielded (Validated) Medical System
- Transitioning from ISO 9001 to CFR - Recently transferred to a Pharma company
- DMR, DHR and DHF physical form
- List of Approved Test Laboratories by FDA
- ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality systems
- The most current version or draft of the Q10 - Pharmaceutical Quality Systems
- Best practices for GMP training
- What should generate a CAPA (corrective action - preventive action)
- Blinding Checks for labels in a clinical study
- Development of IOQ protocols - Validation in the pharmaceutical industry
- FDA holding toothpaste imported from China at Customs for testing?
- The differences between FDA and ISO 9001 Audits
- Dried Food Packaging - Getting FDA registered / approved
- Audit checklist for Cosmetics
- FDA Audit next week
- FDA warns on Hot Dog Chilli Sauce
- FDA warning on canned French Cut Green Beans
- Approval - FDA and ISO Definitions
- FDA Expands Warning on Eating Raw Oysters
- Material Change - New 10993 Testing and Submitting a New 510(k)
- What is the link between FDA and US Pharmacopeia?
- Questions about cGMP in a pharmaceutical company in China
- Customer is FDA Certified - Must we also be FDA Certified?
- Date Stamping for Electronic signatures
- GIVE (Generic Initiative for Value and Efficiency) Launched by the FDA (US)
- Requirements for Registering and Listing with the FDA
- Liability for Packaged Drug products Sold Indirectly in the International Market.
- Applicable Guidelines for Use of Regrind Materials
- Part 11 Requirements - Medical Devices vs. Pharmaceuticals
- Is there such a thing as FDA Good Documentation Practice (GDP)?
- Approximately $2 Million of Potentially Harmful "Cosmetic" Eye Product Seized
- Status of Material Safety Data Sheet (OSHA Compliant) vs. 10993 Certificate
- Statistical Analysis during Document Audit
- FDA Launches Email Alert Subscription Service
- Incorporating the Use of a Specific Software in an SOP - Validation of QA Software
- Obtaining Documents from the FDA in Frame of FOIA
- User Requirement Specification (URS) for off the shelf software.
- Where to draw the line with Red Lining?
- Process Validation needed with IDE Approval?
- Risk Management Software suggestions?
- DMR (Device Master Record) Revision Requirements? FDA GMP Manual
- How often does the FDA inspect organisations outside of the USA?
- 21 CFR Part 11 Compliance - Generation of Complete Copies of Records
- GTP (Good Tissue Practice) & GLP (Good Laboratory Practice) Certification
- Customer Changes to Customer Supplied Documents - Testing Instructions
- Good Documentation Practice (GDP) - Actual Results (can they be typed)?
- FDA Requirements and/or Standard for Infant Formula Glucose Content
- Production and Process Control SOP example or template needed
- Process Validation - Production Line Transferring to a Different Facility
- FDA Proposes Guidance for Dissemination of Info on Unapproved Uses of Med Products
- FWIW: FDA confused?
- Audit of Goods In as part of the QSIT "Production & Process Controls" Schedule
- Tabular Gap Analysis of the EU (volume 4) and US (210/211) cGMP Regulations
- 21 CFR Part 11, "enforcement discretion" - Validation, Audit Trail, Record Retention
- Can a prescription type material be used as a predicate for an OTC material?
- Overall Residual Risk Procedure
- Using Faxed Hand Signatures for Approval Records
- Non-Dairy Creamer - Is there an FDA or other standard for Non-Dairy Creamers?
- Defect Awareness Training - Medical Devices
- FDA on path to establish offices in China
- question on FDA and Health Canada
- The new FDA internet home page - March 2008
- Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements
- EU Validation Requirement vs. FDA Validation Requirement - EN 62304
- Is there an FDA guidance on how to distinguish between Complaint and Repair?
- Effects of substrate on biological indicator organisms
- Has anyone had to do labeling/comprehension testing?
- Company Develops Specifications-Manufacturing is Outsourced-Registration Question
- The Benefits of 21 CFR Part 11
- "Performance Specification" vs. "Specification"?
- Reference to FDA on label or labelling
- Calculation for Similarity and Differences in dissolution profile (F1&F2 Values)
- List of Countries that require 'Certificates to Foreign Governments' (CFG)
- USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process
- FDA Embarks on Major Hiring Initiative for its Public Health Mission
- Email Exposure - Inappropriate statements uncovered in emails
- Laboratory of Assay for Poliolefinas - Section 177.1520 of the FDA and AP89
- SOP - Notification to Management of critical or major quality issues
- Do we need FDA Approval of the Manufacturing Facility and how do you go about it?
- Who is it manufactured by? Manufactured by vs. Manufactured for
- Oral Complaints - CFR 21 Section 820.198-(2) - Medical Devices
- Rework vs. Reprocess - Definitions - Pharmaceuticals
- FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
- Document Approvals and 21 CFR 11 - Electronic signatures and approvals
- Procedure on Traceability - FDA audit finding
- Traceability of Requirements in the V-Model
- Drug product physical properties stability studies - which properties to test?
- Acceptance Activities-Dimensional Inspection was missed. Parts already assembled
- FDA - "Net Quantity of Contents" - Manufacturing filling process
- When the FDA comes a knockin
- California FDB (Food & Drug Branch) inspection experiences?
- FDA quantification of AQLs or Quality Levels
- Temperature and humidity storage requirements?
- Sterile Field - Legal/formal definition
- Understanding FDA requirements for Software Validation
- What are the requirements of traceability in FDA's Regulations
- Sterility (bacteriostasis/fungistasis) Testing by Membrane Filtration validation
- Relationship between "Corrections/Removals" procedure and "Recall" procedure
- Industry Standard for Correcting Dates on Documents
- PMAP (single outside audits for both FDA, HC)--anyone doing?
- Investigator - Lead Study - FDA pitfalls?
- A question arising in my lab in a GLP (Good Laboratory Practice) study
- Plastic film materials that will meet both USP and SP?
- 3rd Party Facility Inspections - In a manufacturer's best interest?
- Only appearance and PCB are changed - Do we need to submit a new 510(k)?
- Proofreading System (CCD camera reading labels) vs. 21 CFR part11
- List of FDA approved Manufacturing facilities (India) ??
- Question regarding Device Master Records & Specification Developers
- When to issue a CAPA (corrective action preventive action)?
- FDA opens new China office in Beijing yesterday
- Use of FDA recognized standards: IEC 62304
- Millions unknowingly taking unapproved meds
- Who does QC (Quality Control) report to?
- Obama’s health team needs your input
- Requirement to save original, handwritten internal audit notes?
- Harmonization of ANSI/AAMI PB70:2003, EN 13795?
- FDA opens offices in India (New Delhi and Mumbai)
- Health Hazard Evaluation (HHE) template needed
- NFPA 99:2005 will have a new edition in 2010 - What will the changes be?
- One website/marketing material for two companies
- New FDA Chief Viewpoints - February 2009
- Any one know about FDA's GMP, 21 CFR Part 111
- Certificate for Foreign Government - How long it takes for an approval?
- GLP (Good Laboratory Practices) Requirements and Audit
- Gearing up GMP based systems for continual improvement.
- President Obama Picks Dr. Margaret Hamburg as FDA Chief
- Change Control for FDA industry - Drug Manufacturer
- List of FDA Required Procedures
- Make GMP product in non-GMP facility?
- New workshop at different address - Do I have to update the establishment info?
- Process Validation (range batch size)
- Does a Company have to appoint a US Agent to sell product in Canada or vise versa?
- Software Requirements specification vs. Design Specification - Differences
- Response to FDA 483. Responded within 14 days and now waiting for reply
- Facility qualification - API (Active Pharmaceutical Ingredient) industry
- A specification developer or not? Contract design and development for a subsystem
- Regulations for Yield Reporting and Evaluation Upon Lot Completion
- Is there anyone who can help me check my instruction booklet
- Standard on Clean room - Where can I buy ISO 14644-1 and ISO 14644-4
- Method for Dew Point and Oil content - Qualifying our Compressed Air System (CAS)
- Accelerate the possesing of ISO 13845 and CAN/CSA-certifications a FDA registration
- Handling, Storage and Distribution-Package validation Test Method Options?
- US FDA plans to launch new website
- Minimum Gowning Requirements for ISO Class 8
- Why does it take so long for a Food Recall to come out?
- Fine Lines and Preorbital Wrinkles - FDA not regulating skin rejuvenation
- Original written signatures vs. Copies/scans/faxes/electronic documents
- FDA Audit Procedure - SOP
- FDA - Registration & Listing Updating +
- Customer Complaint - FDA Definition of Complaint
- FDA guidelines for Calibration Lab needed
- Filter cleaning procedure for Clean Room Air Handling Unit example wanted
- Silly customers - Customer On-Site Audits
- Antimicrobial surface coatings - FDA OAP, Office of Antimicrobial Products
- Barcode Format Question - Variable vs. Fixed Segment Length
- What do we need to do to be certified as a GLP laboratory?
- International Manufacturing Facility Audit
- Why "c" is small for cGMP (current Good manufacturing Practices)
- New sub-forums within the FDA forum
- Does FDA change the information about" wire transfer"
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