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Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

January 27, 2011

 

How to Prepare Yourself for FDA's New Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Validation of Excel® Spreadsheets for Regulated Environments: Step-by-Step

With Case Studies and Validation Protocols for Easy Implementation.

Recorded

 

Understanding and Preparing for FDA's New Part 11 Inspection Program

With 10+ Best Practice Guides for Easy Implementations

Recorded

 

Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

New  release in
2010 

with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.

 

 

Labcompliance News, November 2010

FDA will Join PIC/S in January 2011

According to a press release from November 17, 2010, the PIC/S committee invited the US Food and Drug Administration (FDA) to join the PIC/S as from 1 January 2011. The FDA will become PIC/S’ 38th member. The FDA applied for membership back in September 2005. A first on-site assessment visit took place in August 2009. A follow-up visit to the USA was performed on August 9-13, 2010 in order to review the remaining outstanding issues. Following this visit, the audit team recommended to the Committee to accept the membership application of the US FDA. In addition to the FDA also Ukraine’s State Inspectorate for Quality Control of Medicines (SIQCM) will become a member as of January 1. PIC/S is one of the most important organizations in the area of global harmonization of GMP regulations and inspections. To read the press release, click here.

FDA Warning: Computers Must be Revalidated Before Put in Operation After Changes

When software or computer systems are updated with new software or hardware they should be revalidated before the system is put in operation. This came out of an inspection of a device manufacturer. The company used the reprogrammed software before it has been revalidated. The letter reads:  "Failure to adequately validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm failed to provide documentation detailing the validation prior to production use. Software on both systems were reprogrammed on August 9-10, 2008, and utilized in production on August 11, 2008.  The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-228.  To learn everything about revalidation of software and computer systems: what, when, how  attend the audio seminar  "Revalidation of Computer Systems for FDA&EU Compliance".

EMA Posted Questions & Answers about Post Approval Changes

The European Medicines Agency published the Q&A document on its website. A post-approval change management protocol describes specific changes that a company would like to implement during the lifecycle of the product and how these would be prepared and verified. The document answers questions about the required protocol content, about submission and evaluation procedures and how changes will be implemented after the approval. To read the Q&As, click here.

FDA Guidance for Early Clinical Trials with Live Biotherapeutic Products

FDA announced the availability of a draft document entitled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information” dated September 2010. The draft guidance provides IND sponsors with recommendations on the submission of INDs for early clinical trials with LBPs. This draft guidance focuses on the chemistry, manufacturing, and control information that should be provided in an IND in order to meet the requirements under § 312.23 for early clinical trials evaluating LBPs.

FDA Guidance on the Need of IND for Conducting Clinical Trials

The Food and Drug Administration (FDA) released a draft guidance entitled Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without an IND.'' This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND requirements. To read the draft guidance click here.

Free 76-page Primer on Method Validation Available

This 76-page primer authored by Dr. Ludwig Huber is intended to guide managers and analysts from (bio)pharmaceutical, food, chemical, environmental  and other regulated  laboratories through all aspects of analytical methods validation. Quality managers and staff as well as regulatory affairs professionals will also benefit through extensive discussions of relevant regulations, quality standards and guidelines. The primer is available as e-book at no charge. For more information and ordering, click here.

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP "Reserve Samples in Laboratories". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on October 4, 2010). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

 

  1. Revalidation of Computer Systems for FDA&EU Compliance
    With strategies and tool kits for cost-effective implementation
    December 16, 2010
  2. FDA/ICH Compliant Development and Validation of Stability Indicating Methods
    Sample generation - method development - validation - documentation
    January 20, 2011

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Recent Warning Letters and 483's Related to Computer Validation and
Part 11
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