Skip to main content

Active Substances and Excipients for Medicines - Rules and Requirements



Traininng.com, a leading provider of online professional training courses, will organize an online regulatory compliance training on January 31 on the topic, “Active Substances and Excipients for Medicines - Rules and Requirements”.  Madeleine S. Fairweather, who has been involved in technology transfer and ongoing auditing of API suppliers for over ten years, will be the speaker at this webinar. Please visit to enroll for this webinar


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, since most organizations are likely interested in the markets beyond Europe, such as the USA, Australia, Asia or Japan; she will show how to align their Quality Systems with other international guidelines such as ICH Q7 for current Good Manufacturing Practice of APIs.

Dr. Fairweather will also make a detailed discussion of the ICH Q11, which deals with the development and manufacture of chemical, biotechnological and biological components of drug substances. Another topic she will explain includes what criteria need to be met when it comes to releasing these materials for shipping and further processing.

Online regulatory compliance training for ensuring successful API and excipient sourcing and manufacture

The core of the discussion in this online regulatory compliance training is about the general rules and regulations that must be adhered to in order to ensure successful API and excipient sourcing and manufacture. Dr. Fairweather will discuss the different types of substance and the rules which apply to each and when and how thoroughly to apply cGMP to the phases of manufacturing. Also covered in detail at this webinar are labeling requirements and batch supply chain and considerations for commercially licensed active substances versus APIs for use in clinical trials.

This online regulatory compliance training from this well-known provider of training courses for professionals is aimed at all those whose work involves some element of familiarization with the rules and requirements for selecting, purifying and manufacturing of active substances (active pharmaceutical ingredients or APIs) and excipients for use as starting materials in the manufacture of human or animal medicines.

Labels:

Comments

Post a Comment

Popular posts from this blog

Rewards and Recognitions that Get You What You Want to Achieve

The information that follows applies to human resources personnel and management at all levels.Rewards and recognitions are the responsibility of all involved in the management and development of employees. My belief is that one size does not fit all and in order to achieve the desired outcomes, both task responsibilities and individual differences must be taken into account. Why You have to Know There are numerous elements that decide an association's arrangement around remuneration, advantages, prizes and acknowledgments. Maybe the absolute first choice that should be made is one of the essential estimations of the organization. Is it going to be an organization dependent on rank and security or one dependent on legitimacy - or a blend of the two? Government offices and association controlled associations as a rule settle on the real choices of remuneration around arrangement, rank and security. So too do numerous associations in the corporate world.Smaller organizations
Post a Comment
Read more

Introducing The Simple Way To IDENTITY ISSUES In BANKING

Identity theft is one of the foremost issues for the banking industry. It goes without saying, from an observation of any of the patterns that the fraudsters use for theft, that they are smart. They devise innovative ways to circumvent the system. For example, they don’t use their real name, address or social security numbers when logging in. They could also use stolen or vicarious identities, making investigation a lot harder to carry out. The ways of understanding these complexities will be the topic of a 60-minute webinar from Traininng.com, a leading provider of professional training for all the areas of regulatory compliance. At this valuable session, the expert, Jim George, an independent consultant to banks who focuses on issues of fraud, will be introducing the simple way to identity issues in banking. Please register for this session by visiting ---------------------------------------------------------------------------------------------------------------- Identifying th
Post a Comment
Read more

Electronic Payment Fraud Prevention Best Practices

As online and electronic modes of payment increase in their prevalence, it is a lot easier to transact with money matters than it was a few years ago. One doesn’t need to visit a bank or any other financial institution to make these. One can do so from the comfort of one’s own location. But wait a minute. While these improvements in technology have made our tasks easier, they also come with an inevitable side effect: the potential for fraud. Vulnerability is a byproduct of technology. It is almost inseparable from the benefits that technology brings. Not only individuals around the world, but even organizations are at the receiving end of various smart frauds that dot the electronic payment landscape. Ironical as it may sound, companies don’t have the same levels and layers of protection from electronic payment fraud as individuals. They have less than 24 hours to report the fraud, failing which their chances of recovering their lost money reduce dramatically. So, what is the way
Post a Comment
Read more