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Annual cGMP Training for Pharmaceutical Microbiologists

Held once a year, this comprehensive live training program is a must attend for pharmaceutical microbiologists

 

2019 Annual cGMP Training Program for Pharmaceutical Microbiologists - Latest FDA, USP, ISO, Canadian and EU Guidances and Regulatory Requirements

3-Part Live Interactive Training Program

Part 1: The Laboratory Environment - Date: Thursday June 6, 2019
Part 2: The Manufacturing Environment - Date: Thursday June 27, 2019
Part 3: The Non-Sterile and Aseptic Fill ‘n Finish Environment - Date: Thursday July 11, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)

Instructor: Barry A. Friedman Ph.D. Biography>>>


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The 2019 Annual cGMP Training for Microbiologists will cover the three arenas that primarily involve the Microbiologist in the cGMP environment. These areas include the Laboratory Environment, the Manufacturing Environment, and the Non-Sterile and Aseptic Fill ‘n Finish Environment. “Annual GMP Training” is expected of all employees within a cGMP facility and is required by the FDA on, at least, an annual basis.

The Laboratory Environment, and, in particular, the Microbiology laboratory, have definite Annual GMP Training requirements that necessitate “refreshing”. With a constant influx of new and revised FDA Guidances for Industry, USP General and General Information Chapters, ISO, Canadian and EU requirements, Standard Operating Procedures (SOPs) are always in flux. In addition, with a continuum of Form FDA 483 Observations and Warning Letters providing “new twists” to what is expected of the Microbiology Laboratory Environment, the studying of these FDA compliance documents from a microbiological prospective can be most helpful.

As the microbiologist transitions from the Laboratory to the Manufacturing Environment, additional cGMP issues always arise that require addressing. Whether the facility is considered as a Controlled or Classified environment, whether it is manufacturing non-sterile or aseptically filled product, the Microbiology Environment of the facility is critical to assuring products leave the facility with the microbiology specifications in control. As the facility is examined in additional detail, the environment must also be considered. Both airborne viable and non-viable particulate considerations must be explored and controlled within all areas from ISO 5 to 8. The water systems, which include potable water, purified water and water for injection, will be explored regarding their microbiological requirements, specifications, maintenance, and compliance.

As the product proceeds to its final stage of packaging, both non-sterile and sterile products must be tested for their microbiological content. With non-sterile products, a limited number of microorganisms are acceptable; with sterile products, no microorganisms may be present. Often issues of OOT, OOS and CAPAs become critical at this juncture point. The webinar will review what is and what is not acceptable.

The objective of this comprehensive three part Pharma Webinars' instructor led training program on Microbiology “Annual cGMP Training for Microbiologists” is to obtain an enhanced understanding as well as a “refresher” of what requirements exist for the microbiologist throughout the production environment from In-coming through final release. A review of Case Studies/Warning Letters pertinent to all phases of the microbiologist’s environment will be reviewed to enhance the learning benefits of this PharmaWebinar series.

The complete course agenda detailing each individual session can be found below.

Training Program Learning Benefits:

- Gain an overall review of cGMP and those sections of 21 CFR 211 that impact microbiology from In-coming through Fill ‘n Finish and release.
- “Refresh” your understanding of microbiological issues that impact the Laboratory.
- Review USP, 21 CFR 211, EP, Canadian, ISO and various FDA Guidances that impact microbiological issues throughout the cGMP environment for the microbiologist within Manufacturing/QC operations.
- Learn how microbiology impacts In-coming Raw Materials.
- Review non-sterile products and how USP<61>, <62>, and <1115> impact these products.
- Review aseptically produced products and how the revised USP<1116> may impact any observed contamination within the Clean Room environment.
- Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment.
- Learn how Quality Agreements Impact Microbiological Issues within the Laboratory and throughout manufacturing.
- Review various Case Studies that involve Form FDA 483s and Warning Letters.

Part 1: The Laboratory Environment

Date: Thursday June 6, 2019

Webinar outline and time breakdown:
Time*

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM History of cGMPs, their Rationale for Existence and How Microbiology Impacts Them,
21 CFR 211 and Its Impact on Microbiology,
Other Regulations and Guidances and Their Impact upon Microbiology ,
Issues within the Microbiology Laboratory and How Best to Address Them,
Obtaining Adequate Samples, Their Storage and Use within the Laboratory,
11:30 AM Break
11:40 AM Endotoxin Related Issues,
Deviations, Out of Specifications and Out of Trend and Their Impact on The Laboratory,
The Use of Metrics to Assess Problem Solutions,
Frequency of 21 CFR 211 Microbiological Observations,
Case Studies to Include Form FDA 483s and Warning Letters,
12:30 PM Live Questions & Discussion


Part 2: The Manufacturing Environment

Date: Thursday June 27, 2019

Webinar outline and time breakdown:
Time*

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Microbiology and the Controlled/Classified Manufacturing Environment,
Control of Numbers/Species of Microorganisms in the Non-Sterile Manufacturing Environment,
Airborne Viable/Non-Viable Particulates and the Manufacturing Environment,
Disinfectants and Antiseptics USP<1072> and Related Issues,
11:30 AM Break
11:40 AM Water Systems and Their Control Within the Manufacturing Environment,
Developing a Microbiological Sampling Plan Throughout the Batch Record,
Frequency of 21 CFR 211 Microbiological Observations,
Case Studies to Include Form FDA 483s and Warning Letters,
12:30 PM Live Questions & Discussion


Part 3 : The Non-Sterile and Aseptic Fill ‘n Finish Environment

Date: Thursday July 11, 2019
Webinar outline and time breakdown:
Time*

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Considerations of USP<61>, <62> and <1115>,
Issues with Non-Sterile Product in a Fill ‘n Finish Environment,
Number and Species of Microorganisms Permitted in Non-Sterile Products,
Issues with Sterile Products in a Fill ‘n Finish Environment,
A Review of the Revised USP<1116>,
Gaining an Understanding of USP Sterility Tests<71> and the Impact of a Positive Result,
11:30 AM Break
11:40 AM Deviations, Out of Specifications and Out of Trend and Their Impact on The Final Product,
The Use of Metrics to Assess Problem Solutions
Frequency of 21 CFR 211 Microbiological Observations Within Final Products
Case Studies to Include Form FDA 483s and Warning Letters,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This comprehensive 3-Part live training program includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Microbiology Personel
  • Project Managers
  • Those that use contract manufacturing and contract testing facilities

Click Here to Register for this Live Training Program

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 


 
 

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

Live Training Benefits:

• Pharma Webinars training webinars and programs are presented exclusively as live events only.

• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.

• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.

• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.

• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.

• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.

• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.

• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.

• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.


Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland

Clients: