All Blog Posts (1,403)

Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.

In the absence of these guidelines, many organizations end up…

Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.

In the absence of these guidelines, many organizations end up…

If you have a colleague who gets down to hairsplitting detail at every work she undertakes, to the extent that she takes half a day to complete a task that can be done in half an hour, you have a person with OCD in your midst. Obsessive Compulsive Disorder is a psychological condition in which the person with it is too obsessed with perfection. This penchant for perfection in everything they do can be painstaking for others who interact with them, but for those with…

Fortune 500 companies and small family businesses alike share a business need - insuring that they have the talent necessary to effectively lead their organizations in the future. One of the most significant contributions a leader can make is insuring his/her business'continuity and sustainability - by having employees who are willing and capable of filling each key position with a plan for doing so when the need arises.

Succession Planning is a:

• Deliberate, systematic…

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a 60-minute webinar on the topic, “Why & How do we Fail an FDA Inspection”. Vikram Kulshreshta, a Senior Management Professional with a strong experience in Quality Assurance & Regulatory Affairs, will be the speaker at this session. Please visit…

Traininng.com, a well-known provider of professional training for all the areas of regulatory compliance, will organize a 60-minute webinar on the topic, “The New EU Medical Device Regulation”, on February 21. Dr. Salma Michor, who is the founder and CEO of Michor Consulting Schweiz GmbH, who teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission, will be the speaker at this valuable…

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will organize a webinar on the topic of HPLC Analytical Method Development and Validation, on February 21. John Fetzer, a senior professional in HPLC methods, will be the speaker at this session.

Please visit http://bit.ly/2SEmev3 to enroll for this webinar and gain insights into the core aspects of how to carry out…

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety.

This course will also review…

The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.

Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new…

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.

Please visit http://bit.ly/2GFGiXr to enroll for this webinar.

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A complaint says a lot about a product. It helps the…

Preliminary risk assessment (e.g., Likelihood X Impact) and the results of previous audits (e.g., number of NCs) are often used to help prioritize the audit schedule. While these are worthwhile to consider, they do not necessarily reflect the real-time performance of the processes that could be included in the audit plan. This means many audits are likely investing time and human resources in looking at processes that are performing adequately, while others that might be at greater risk are…

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs”.

Doug Keipper, a Certified Anti-Money Laundering Specialist (CAMS) and a former Bank Secrecy Act officer and compliance officer, will be the speaker at this webinar. Please visit…

Traininng.com, a reliable provider of professional training for the areas of regulatory compliance, will organize a webinar on the topic, “Rolling Forecasts: The New Way to Budget”, on February 11. The speaker at this 75-minute session is Carl Young, a senior finance and business professional.

Please visit…

Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the…

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

• ISO standards and FDA/MDD regulations regarding the use of statistics.
• Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
• Statistical…

Quality Assurance, Quality Systems, quality risk management and Quality Control are the cornerstones of Good Manufacturing Practices (GMP). Being a globally acclaimed provider of training courses for professionals, Traininng.com introduces these concepts at this online regulatory compliance training webinar.

The expert, Dr Madeleine S. Fairweather, will present these concepts in accordance with EU GMP Part II. However,…

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review…