Food, Drugs & Biologics
Food is a vital and basic need to sustain life. Over time various government bodies have established and set parameters, standards and guidelines that decide the production methods, the distribution as well as the packaging and quality standards. The U.S. Food and Drug Administration has established itself as the prime governing body by providing regulatory guidance while protecting and promoting public health through the regulation and supervision of food safety. Webinar Compliance will provide valuable insight through our training sessions into various aspects of Food Compliance like prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and dietary supplements through industry experts.
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10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love
For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data... -
2-Hour Comprehensive Seminar on Measurement Systems Analysis
Attendees will also receive an Excel spreadsheet with the d*2 factors that are required for the average and range method, and another with data for the worked examples. These appear in some references that are named in the handout,... -
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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation... -
21 CFR Part 11 Compliance for Electronic Records and Signatures
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11.... -
3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it... -
3-Hour Certification Course on Good Manufacturing Practices (GMP) – An Introduction
Good Manufacturing Practices (GMP) are a cornerstone of life sciences production. In fact, this decades-old regulation is so important that nearly everyone from discovery through product production should have a working knowledge of it. Despite this, even those directly... -
3-Hour Virtual Seminar on 510(k) and PMA Submissions Process
The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its... -
3-Hour Virtual Seminar on Bad Standard Operating Procedures (SOPs) – Bad Training: Garbage In, Garbage Out
Standard Operating Procedures (SOPs) are necessary to demonstrate compliance with regulations and operational practices. It also serves as a documented roadmap which ensures consistency. This is integral to a strong quality system. If you want to improve SOPs writing... -
3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA’s current thinking on computer... -
3-Hour Virtual Seminar on cGMP Regulatory Inspections – Through the Eyes of FDA, EMA and PMDA
GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national... -
3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance... -
3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
3-Hour Virtual Seminar on Effective Cleaning Validation Procedures – Best Practices
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,... -
3-Hour Virtual Seminar on Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor.... -
3-Hour Virtual Seminar on Establishing a Robust Data Integrity Program
Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on... -
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used...
Pharmaceutical, drugs and biologics are under the strict scrutiny of bodies like the US FDA and the ICH (International Conference on Harmonization). These regulatory bodies make it critical for professionals to understand the most up-to-date compliance regulations and how to avoid non-conformance. The FDA and ICH monitor the drug manufactures to ensure that they comply with the existing and updated standards of drug and pharmaceutical production like the cGMP (Current Good Manufacturing Prctices) and the GxP’s (GMP,GLP,GCP & GDP). Webinar compliance offers the latest and up-to-date pharmaceutical training webinars and courses to help you ensure compliance.
Biopharmaceuticals or Biologics use living organisms as production systems to manufacture complex, biologically active proteins. However, this involves extreme uncertainty and complexities.
To ensure that the manufacturing of biologics are safe and efficacious and secure for the general public and health, accurate understanding on how to meet the CMC (Chemistry, Manufacturing & Controls) regulatory requirements for biosimilars (FDA, EMA and WHO).
Webinar Compliance has brought together industry experts; helping companies in FDA-regulated industries achieve regulatory compliance throughout the product life cycle (IND & PMA) through SOP and GxP training, compliant to FDA’s 21 CFR Part 11 guidance for electronic records, documents, signatures and more. Our training courses and webinars would cover regulations both current and upcoming content so that regulatory professionals have the right tools and the information to guarantee compliance.