The 2023 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 live training webinar will review what is and what is not acceptable.

The objective of this comprehensive three part instructor led training program 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 live training webinar 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

Webinar outline and time breakdown:

Thursday August 24, 2023 Time*

10:15 AM Log-In Period

10:30 AM Introduction

                History of cGMPs, their Rationale for Existence and How Microbiology Impacts Them,
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 10 Minute Break

                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, Br/> Case Studies to Include Form FDA 483s and Warning Letters,

12:30 PMLive Questions & Discussion

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

Part 2: The Manufacturing Environment

Webinar outline and time breakdown:

Thursday September 7, 2023 Time*

10:15 AM Log-In Period

10:30 AM Introduction

                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 10 Minute Break

                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 PMLive Questions & Discussion

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

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

Webinar outline and time breakdown:

Thursday September 21, 2023 Time*

10:15 AM Log-In Period

10:30 AM Introduction

                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 10 Minute Break

                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 PMLive Questions & Discussion

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

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

Who should attend:

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

• Quality Assurance Personnel
• Quality Control Personnel
• Regulatory Affairs Personnel
• Microbiology Personnel
• Research & Development
• Research & Development
• Those that use contract manufacturing and contract testing facilities

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.