cGMP System Strategies for Cost effective Compliance

Instructor: Garry Bandel
Product ID: 700167
Training Level: Basic
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


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This FDA compliance training offers pragmatic approach to dealing with FDA mandated quality systems. The approach offered emphasizes function over form. Anyone subject to 21 CFR Parts 210, 211 and 820 will benefit from this seminar.

This course addresses questions such as "how much documentation is enough?" and "what is the appropriate level of rigor for my process validation?"

Areas Covered in the seminar:

  • Simplifying GMP Documentation
  • Strategies for Validation/Qualification
  • Strategies for Effective Investigations

Who Will Benefit:

  • QA Personnel
  • Technical Writers
  • Investigators
  • Validation Engineers
  • Manufacturing Operations Personnel

Instructor Profile:

Garry Bandel, Consultant, Federal Regulatory Policies & Strategic Quality Planning Garry Bandel has over thirty-two years of experience in the manufacturing and quality assurance departments for organizations in the life sciences industry. Most recently he served as the Director of Investigations for Abbott Laboratories Hospital Products Division. In that position he developed and implemented a program to assure that investigations of quality problems in each of the plants in the Division identified root cause and implemented corrective actions that prevented reoccurrence. Garry also spent 16 years of his career as the Quality Head of four different manufacturing facilities in 3 different states in two different Divisions. During his tenure in those facilities there were no product recalls and no warning letters.

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