Be up-to-date with GMP Guidelines: 7 Interactive courses by Industry Experts

The FDA's regulations on Current Good Manufacturing Practices (cGMP) affect many different phases of pharmaceutical, biologic and biopharmaceutical development. Good Manufacturing Practices (GMP) are a set of measures that aim to provide guidance for manufacturing, testing, and quality assurance in order to ensure that drug products are safe for human consumption. This Package training course is suitable for everyone who needs to be up-to-date with the GMP guidelines. This package of seven webinars contains beautifully designed, interactive presentations that will allow you to enjoy the learning process and easily understand the fundamentals of Good Manufacturing Practice.
Instructor: Angela K. Dunston, Ludwig Huber, Max Lazar, Charity Ogunsanya, Angela Bazigos
Product ID: PACK70045

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Senior management
  • Project Managers
  • Packaging Experts
  • Auditors and Staff
  • IT Subject Matter Experts
  • Regulatory Affairs management and personnel
  • Compliance Officer and personnel
  • Quality Assurance management and personnel
  • Research and Development
  • Contract Manufacturing and Contract Testing Facilities
  • Laboratory managers and supervisors
  • GMP auditors
  • Teachers
  • Distribution and even Development personnel that are Supervisory
  • Manufacturing Associates Personnel and Management
  • Facility and Utility Personnel and Management
  • Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals
  • Shipping and Receiving Personnel and Management
  • Materials Handling Personnel and Management
  • Supplier Quality Personnel and Management

Webinars included in the Package:

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)(Duration: 120 Minutes)

A number of times there is industry confusion regarding the difference between GLPs and GMPs. 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and do not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not "watered down" GMPs. Good Manufacturing Practice (cGMPs) represents that part of Quality Assurance that ensures the products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification. Non-clinical laboratory studies (58.1) support or are intended to support application for research or marketing permits for various products. GLPs do not include manufacturing product. Non-clinical Laboratory Studies (58.3) include in vitro or in vivo experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects or clinical studies or field trials in animals.

Objectives of the Presentation:

  • Gain insight into "Good Laboratory Practices" (21 CFR Part 58)
  • Learn what GLPs are and are not
  • Understand the basic elements of GLP
  • Learn about management responsibilities and "Sponsors"
  • Understand the Quality Assurance Unit Responsibilities
  • Understand the purpose of the study protocol and its importance in conducting acceptable studies
  • Determine the elements of a Final Report and why they are important
  • Compare and contrast all of the above GLP elements with Good Manufacturing Practice (GMP)

Instructor Profile:

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

Combination Products-The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products(Duration: 120 minutes)

The FDA has ensured that clear FDA requirements were in place for drugs, devices, biological produces as well as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). However, there were no regulations in place to clarify and explain the application of cGMP requirements for combination products. The FDA is seeking to change that with the issuance of a guidance document that describes and explains the final rule on cGMP requirements for combination products. This webinar is in place to describe and explain the FDA current thinking by reviewing the guidance document in detail.

Objectives of the Presentation:

  • Key definitions
  • Overview of Final Rule
  • The role of the Lead Center and other Agency Components
  • How to demonstrate compliance
  • cGMP requirements as they apply to product or facility
  • Control of changes
  • Review of 21 CFR 4.4(b)
  • Primary Mode of Action

Instructor Profile:

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

GMP Compliance for Quality Control and Contract Laboratories(Duration: 75 minutes)

Even though CGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with up-to-date requirements and implementation. Quality control laboratories are considered high risk because after testing and approval, pharmaceutical drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC and related contract laboratories.

Objectives of the Presentation:

  • FDA and international regulations and guidelines
  • Current inspection practices and most frequently found deviations
  • Major differences between GMP and non GMP laboratories
  • Compliance along the laboratory workflow and most critical steps
  • Developing a laboratory compliance master plan
  • The importance of a compliance team
  • Developing a project plan for step-by-step implementation
  • Implementing key requirements

Instructor Profile:

Ludwig Huber Ph.D., is the director of Lab compliance, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.

Reducing your Exposure to a GMP FDA Warning Letter(Duration: 75 minutes)

Attending this webinar will help participants understand how even simple things can affect FDA actions in the future. You will learn what actions and steps are important during and after an inspection. Understanding what you should and should not do with FDA plays a major role in preventing regulatory action that could have been avoidable. This webinar will also examine how to proceed if you do receive 483 observations and what actions on your part can reduce the probability of getting a Warning Letter from the FDA.

Objectives of the Presentation:

  • Learn what should you do after the inspection is over?
  • What should be fixed immediately and why?
  • Time commitments to consider in your interactions with FDA
  • Understanding retrospective reviews that may be appropriate
  • What prospective actions should be considered?
  • Procedural revisions that may be considered and implemented
  • Learn why: Speed is always a consideration

Instructor Profile:

Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance.

CGMP Controlled Raw Materials (Duration: 60 minutes)

This webinar will allow attendees to gain an understanding on the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of a 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.

Objectives of the Presentation:

  • Regulatory Requirements for all Incoming cGMP Controlled Raw Materials
  • Receipt and Storage of cGMP Controlled Raw Materials
  • Processing New cGMP Controlled Raw Material Specification
  • Procedure for Raw Material Initial Receipt
  • Performing the Verification Checks
  • Test Requirements for Routine and Confirmatory Testing of Qualified cGMP Controlled Raw Materials
  • Evaluation of Suppliers and Manufacturers of cGMP Controlled Raw Materials after Approved Specification Changes
  • Disqualification of cGMP Controlled Raw Materials Test Parameters
  • Requirements for the Comparison Criteria Used in the Confirmatory Yearly Testing
  • CGMP Controlled Raw Material Confirmatory Testing Process
  • Documentation of cGMP Controlled Raw Materials
  • Investigating OOS Associated with Rejected cGMP Controlled Raw Materials

Instructor Profile:

Charity Ogunsanya is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.

US, EU and Japan GMP Requirements- Practical ICH Area Differences and Healthcare Inspection Focus(Duration: 90 minutes)

This webinar reviews the latest developments in ICH Q7 GMP harmonization between US, EU and Japan. It describes how the advent of this guidance impacts the different countries and explains why the regulatory authorities of each country, still have divergent expectations, despite the harmonization. It then explains how to overcome the differences in the expectations of the US, EU and Japan regulatory authorities, to ensure successful inspections with minimum additional cost or effort.

Objectives of the Presentation:

  • U.S., EU and Japan GMPs - Status of Harmonization& FutureTrends
  • Where Inconsistencies Become a Problem: WHO, ICH, Countries
  • Compliance with ICH Guidelines for GMPs
  • APIs
  • Finished Products
  • Excipients
  • Sterile products
  • Biologics
  • Clinical Packaging
  • Area GMP Inspections
  • Auditing Your Facilities for Global Considerations

Instructor Profile:

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

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