WEBINARS

 

Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703875

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

7 / Dec / 2021 - Tuesday

* Per Attendee $249

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

7 / Dec / 2021 - Tuesday

* Per Attendee $229

 

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703476

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

9 / Dec / 2021 - Thursday

* Per Attendee $229

 

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 705164

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703727

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Recording Available

* Per Attendee $299

 

Process Analytical Technology (PAT): The Impact on Pharmaceuticals Manufacturing and Validation Needs/Requirements

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 701147

This webinar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) and will be an invaluable source of information on various technologies and approaches that fit the PAT definitions. You will learn about regulatory initiatives to improve the quality of pharmaceutical manufacturing using PAT and validation thereof. No special technical background is required.

Recording Available

* Per Attendee $299

 

How to Implement the FDA SUPAC Guidance

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 704312

This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.

Recording Available

* Per Attendee $299

 

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 704617

The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

CGMP controlled Raw Materials

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705148

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.

Recording Available

* Per Attendee $399

 

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704659

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Recording Available

* Per Attendee $299

 

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 702540

This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.

Recording Available

* Per Attendee $349

 

How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 704885

This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.

Recording Available

* Per Attendee $249

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Recording Available

* Per Attendee $249

 

How to Conduct Successful Supplier Audits

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704499

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

Recording Available

* Per Attendee $249

 

Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

webinar-speaker   Travis Austin MacKay

webinar-time   60 Min

Product Id: 705497

This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.

Recording Available

* Per Attendee $279

 

How to write SOP's that Avoid Human Error

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704418

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Recording Available

* Per Attendee $299

 

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

webinar-speaker   Travis Austin MacKay

webinar-time   120 Min

Product Id: 702317

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.

Recording Available

* Per Attendee $349

 

Root Cause Analysis - The Heart of Corrective Action

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 703391

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

Recording Available

* Per Attendee $299

 

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703831

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

Recording Available

* Per Attendee $299

 

DEA, Your Registration and How to Lose It

webinar-speaker   Carlos M Aquino

webinar-time   120 Min

Product Id: 701992

This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.

Recording Available

* Per Attendee $349

 

 

 

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