WEBINARS

 

Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

8 / Nov / 2021 - Monday

* Per Attendee $199

 

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.

16 / Nov / 2021 - Tuesday

* Per Attendee $249

 

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.

17 / Nov / 2021 - Wednesday

* 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

 

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

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

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.

Recording Available

* Per Attendee $279

 

Proper Execution of Annual Product Reviews

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704993

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.

Recording Available

* Per Attendee $299

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Japan: Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702979

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Recording Available

* Per Attendee $299

 

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 701367

This DMFs (Drug Master File) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

Recording Available

* Per Attendee $299

 

Understanding and Implementing a Quality by Design (QbD) Program

webinar-speaker   Steven Laurenz

webinar-time   60 Min

Product Id: 705001

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.

Recording Available

* Per Attendee $299

 

4-Hr Virtual Training: How to Respond to an FDA Investigation

webinar-speaker   Joy McElroy

webinar-time   4 hrs

Product Id: 704549

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.

Recording Available

* Per Attendee $449

 

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

webinar-speaker   Carlos M Aquino

webinar-time   60 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

 

OTC Drug Regulations

webinar-speaker   Loren Gelber

webinar-time   60 Min

Product Id: 705446

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.

Recording Available

* Per Attendee $279

 

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704316

This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.

Recording Available

* Per Attendee $299

 

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704313

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

Recording Available

* Per Attendee $299

 

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703066

This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.

Recording Available

* Per Attendee $299

 

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704302

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.

Recording Available

* Per Attendee $299

 

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

webinar-speaker   Norma Skolnik

webinar-time   60 Min

Product Id: 704371

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.

Recording Available

* Per Attendee $249

 

 

 

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