GXP Pharmaceutical Training

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.

This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.

In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.

This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.